BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2905124 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19062
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP, IT WAS LEARNED THAT THIS DEVICE WAS EXPLANTED DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS. TTE ON (B)(6) 2012 REVEALED A VEGETATION ON THE VALVE. INTRA-OP TEE ALSO SHOWED SIGNIFICANT VEGETATION ON THE DEVICE. DURING INSPECTION, THERE WAS OBVIOUS OVERGROWTH WITH ACUTE INFLAMMATION CONSISTENT WITH THE PRE-OP DIAGNOSIS OF PROSTHETIC VALVE ENDOCARDITIS. AFTER IMPLANTATION OF A NEW EDWARDS BIOPROSTHETIC VALVE, TEE REVEALED EVIDENCE OF MILD CENTRAL AORTIC INSUFFICIENCY WITH A WELL-SEATED VALVE WITH MINIMAL GRADIENT ACROSS THE VALVE OF 5 MMHG. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 MONTHS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10502 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R