FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY)

Date of Recall

2011-12-15

Recall Details

- December 14, 2011 - St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.

The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA's classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company's website, www.sjmprofessional.com. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the Physician Advisory Letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.

St. Jude Medical reiterates that all leads with an externalized conductor, with or without an associated electrical abnormality, be reported to the company's Technical Services Department at 1-800-722-3774. The company strongly encourages that any experience with screening of Riata leads for externalized conductors be shared with the company, including information regarding a lead or leads in which externalized conductors are not present. If a lead has been removed from the patient, St. Jude Medical requests that it be returned to the company, at company expense, for failure analysis to further understand this particular failure mechanism. All reports and returns received by St. Jude Medical of Riata leads exhibiting externalized conductors, irrespective of whether there is an associated electrical abnormality, are reported to FDA as a Medical Device Report (MDR). Any adverse reactions experienced with the use of this product, and/or quality problems also should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

St. Jude Medical acknowledges that the clinical implications of leads with electrically intact externalized conductors are not fully known at this time. Consequently, more data are required in order to assess if specific patient subgroups with electrically intact externalized conductors are at greater risk or should be managed differently. Patients who require frequent defibrillation or who are pacemaker dependent may be considered to be at greater risk. It is recognized that physicians may choose to individualize the approach to management of electrically intact externalized conductors based on individual patient characteristics. The potential risks associated with externalized conductors as well as the potential risks and benefits of management options should be considered and discussed with patients.

No comments have been posted.
Be the first to add a comment!