FDA Adverse Event Death Summary report: N

REPLACEMENT HEART VALVE

MDR report key: 1914779 · Received December 4, 2010

Report

Report Number: 2015691-2010-14484
Event Type: Death
Date Received: December 4, 2010
Date of Event: January 3, 2010
Report Date: November 4, 2010
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL NUMBER: THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. DEVICE NOT RETURNED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. INVESTIGATION IS ON-GOING.

Description of Event or Problem · 1

AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT'S FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 MONTHS (9.77 MONTHS) DUE TO UNKNOWN REASONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		REPLACEMENT HEART VALVE	DYE	EDWARDS LIFESCIENCES	SEE H10	08L291

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Death\| H\| R