BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1953173 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14630
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 10, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: IN THIS CASE, PER THE OPERATING SURGEON, THE ENDOCARDITIS WAS A RESULT OF AN INFECTION THAT THE PATIENT SUFFERED AFTER ANKLE SURGERY 3 YEARS AFTER THE VALVE WAS IMPLANTED. UNFORTUNATELY, THE DEVICE IS UNAVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS INITIALLY REPORTED THAT AN EDWARDS VALVE WAS EXPLANTED ON (B)(6) 2010. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE EXPLANTED ON (B)(6) 2010 WAS A MEDTRONIC PORCINE VALVE. HOWEVER, UPON REVIEW OF THE OPERATIVE REPORT IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY HAD AN EDWARDS VALVE (IMPLANTED IN 2001). THE PATIENT HAD SURGERY ON HER ANKLE IN 2004 AND DEVELOPED ENDOCARDITIS. SHE THEN UNDERWENT REDO AORTIC VALVE REPLACEMENT, AT WHICH THE EDWARDS VALVE WAS EXPLANTED AND THE MEDTRONIC VALVE WAS IMPLANTED. NO OTHER DETAILS REGARDING THE EXPLANT OF THE EDWARDS VALVE IN 2004 ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 1B0292

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention