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Issues:

Plaintiff was admitted to a health care facility with ventricular tachycardia (VT). He had a normal coronary angiography with moderate left ventricular (LV) function and was referred for an implantable cardiac defibrillator (ICD) implant procedure. A diagnosis of right ventricular outflow tract tachycardia was made. He was then admitted for an ablation procedure in March 2005, which was successful. In April 2005, he was readmitted with a further occurrence of tachycardia which required emergency cardio version due to hemodynamic compromise and a temporary pacing wire was placed. There was a further attempt at ablation that was again successful and the LV function noted now to have deteriorated and was noted as having poor functioning. On this basis he was considered a candidate for an ICD implant. There was a further reoccurrence of an episode of ventricular tachycardia (VT) in March and April 2006 which was treated medically and he was discharged.

Patient was reviewed by a cardiologist in June of 2006 who noted some improvement of LV function. The data was then reviewed by another cardiologist who was suspicious of ARVC and recommended an ICD to be implanted into plaintiff. He was then seen by another cardiologist who further recommended an ICD to be implanted into plaintiff. He was then admitted for ICD implantation on 29 October 2007 at a health care facility. He was fitted with a St. Jude Medical, Riata 1580 active fixation lead (Lead model: CD1219-36) and a St. Jude Medical Atlas + VR - 193 ICD device (Serial number: 00ABA35620). A pericardial rub was heard post operatively with minimal pericardial fluid. He was reviewed by a cardiologist in March 2008 where it was noted that the device was functioning normally. A differential diagnosis of ARVC with left ventricular (LV) involvement was made in January of 2009.The ICD box was also changed at that point in time due to battery depletion noted on 13 September 2010. Ventricular fibrillation (VF) was induced and was appropriately detected and shocked by the ICD. In October 2013 plaintiff suffered a serious cardiac event and was subsequently pronounced dead in October 2013.

Summary of Key Facts Relied Upon:

CASE RELATED ICD DEVICE AND LEADS USED

The St. Jude Medical V-193 Atlas+ VR ICD (Serial Number: 00ABA35620and the St. Jude Medical, Riata 1580 active fixation lead (Lead model: CD1219-36) had been used on plaintiff

CASE RELATED ADVERSE MEDICAL DEVICE ADVISORIES AND RECALLS

FDA Medical Device Recall(s)

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:

  • Riata (8F) Silicone Endocardial Defibrillation Leads Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
  • Riata ST (7Fr) Silicone Endocardial Defibrillation Leads Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

Testing and Analysis conducted by St Jude Medical Testing Facility:

They confirmed that the Device failed to deliver any shock therapy on 7 October 2013 in spite of the device recognizing VF. The arrhythmia was appropriately identified and the Device attempted to deliver a high voltage shock but was unable to do so due to over current detection during the shock, i.e. the device detected an abnormality that meant that the circuit was not intact and thus the shock could not be delivered. In this report prepared by St. Jude dated 15 November 2013, they confirmed the following (as listed on the following) in their disclosures as well as my reviewing the "Plaintiff's medical records" as provided by attorney for the claimant's family-

  • Premature battery depletion
  • Arc marks on the edge of the can
  • Lead conductor metals detected in arc marks
  • Shocked aborted due to over current detection
  • 5 episodes of VF diagnosis
  • External defibrillation only temporarily converted VD
  • HV lead issue alert from
  • HV impedance below minimum levels
  • Device passed all of the tests
  • No lead available for testing St. Jude

My Conclusions:

Within the bounds of reasonable engineering and scientific certainty, and subject to change should additional information become available, it is my professional opinion that the following had been considered in this matter:

RANGE OF OPINIONS ON THE MATTER

  • Lead Failures due to Inside-out abrasions
  • Lead Failures due to Outside-in abrasions

Additionally, the Expert does appreciate the peer review publications provided by the Defendant as well as all Disclosures provided by St Jude to the Claimant's representatives

EXPERT COMMENT (1)

The publications as provided by St. Jude Medical as of this date do not provide ample support for the position they have taken in this case and many in the Expert's opinion do not adequately support the position they have taken on this case. The Expert has provided numerous peer review publications (which reflect lead failure issues which inhibit the ICD as used in plaintiff that regardless of the mechanism of failure, the ICD did not deliver the level of safety that patients would expect to receive.

This Expert's report included discussion of several peer review publications (including additional and more relevant publications as those provided by St. Jude); MRSA and FDA device advisories & recalls; and additional materials listed as documents reviewed which confirm both that both-

  • Abrasions (outside-in) in the pocket portion of this ICD as used on plaintiff is a potential area where the ICD leads used in the claimant could have failed, resulting in the failure of the device not to deliver the appropriate shocks to alleviate the VT that had occurred and thus leading to his death.
  • The metal marks as found on the can of the ICD as disclosed by St. Jude illustrate the occurrence of an outside-in failure which can result in a short circuit in the ICD's Shock Coil and also result in the failure of the ICD to deliver appropriate shocks to plaintiff as described in Plaintiff's Medical Records.

REASONS FOR EXPERT'S OPINIONS

  • Peer Review Publications provided by Expert and Claimant
  • MAUDE listings as listed in previous sections of this report
  • Events disclosed by both Defendant and Claimant
  • Failure of the Defendant to adequately support his position
  • Device Analysis conducted and conclusions drawn by Defendant
  • December 2011: MHRA Medical Device Alert (MDA/2011/112)
  • 13 July 2012 Field Safety Notice
  • 10 September 2012 MHRA Medical Device Alert (MDA/2012/061)
  • Incident Report involving ICD/Lead Failures
  • Plaintiff's Medical records
  • Insulation breaches as cited in numerous references
  • Can "appeared to be swollen" provided by St. Jude Medical.

In conclusion, it is the humble opinion of this expert who has been retained by the "Claimant", that based on the preceding documents from plaintiff's attorney, St. Jude Medical Disclosures and from peer review publications, and FDA, Expert's opinions cited in this Report that the ICD implant device (The V-193 Atlas+ VR (Serial Number: 00ABA35620) and the St. Jude Medical, Riata 1580 active fixation leads (Lead model: CD1219-36) used in (Claimant failed and that regardless of the mechanism of failure, the ICD did not deliver the level of safety that patients would expect to receive due to both an outside-in and inside-out abrasions to the ICD leads). Additionally the expert is cognizant of the fact that he did not actually test the ICD or the leads in this case, but it should have been obvious that there are numerous documented cases that have confirmed the failure of the Riata leads to function properly as the one's used in case by examining the FDA and MRSA documents issued, the peer review publications which have been discussed and reviewed by the Expert. And that the percentage breakdown of the lead failures due to either lead failure mechanism discussed, both mechanisms, i.e. outside-in and inside-out contribute to a much higher rate of lead failure as stipulated by the Defendant (St. Jude). And either of these mechanisms will result in the failure of the ICD device to have delivered the appropriate shock levels to plaintiff when he was in VT

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George Yanulis, MEng, MS, DEng, is a nationally recognized Cardiovascular Device Product Development and Research Engineer and has conducted cardiovascular device research at the Cleveland Clinic Foundation. He has published in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices. Dr. Yanulis has a Doctorate in Engineering in a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

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