BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2181757 · Received July 27, 2011

    Report

    Report Number
    2015691-2011-15958
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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. IN THIS CASE, THE SOURCE OF INFECTION HAS BEEN REPORTED AS DENTAL PROCEDURE (TOOTH EXTRACTION AND DECAY) BY THE HEALTHCARE PROVIDER. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS' AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 60 MONTHS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT EXPERIENCED SEVERE PERIVALVULAR LEAK AND AORTIC INSUFFICIENCY DUE TO ENDOCARDITIS. THE HEALTHCARE PROVIDER INDICATES THAT THE SOURCE OF INFECTION IS DENTAL PROCEDURE. OPERATIVE REPORT INDICATES, "THE PATIENT RECENTLY PRESENTED TO HIS CARDIOLOGIST WITH INCREASING SHORTNESS OF BREATH AND LOW GRADE FEVER. THE PATIENT ALSO RECEIVED A SHOCK FROM HIS DEFIBRILLATOR FOR VENTRICULAR FIBRILLATION. HIS WORKUP INCLUDED ECHOCARDIOGRAPHY, WHICH SHOWED A SEVERE PERIVALVULAR LEAK. THE PATIENT HAD MULTIPLE BLOOD CULTURES WHICH WERE NEGATIVE...TEE SHOWED AORTIC INSUFFICIENCY WITH NORMAL LEFT VENTRICULAR FUNCTION. THERE WERE NO VEGETATIONS AND NO AORTIC ROOT ABSCESS SEEN. THE PATIENT ALSO HAD A PANOREX, WHICH SHOWED A LIKELY DENTAL ABSCESS AND SEVERE TOOTH DECAY. THE PATIENT DID UNDERGO A FULL TOOTH EXTRACTION AND THEN WAS BROUGHT TO THE OPERATING ROOM URGENTLY FOR AN AORTIC VALVE REPLACEMENT. THE PATIENT WAS IN CLASS IV CONGESTIVE HEART FAILURE...[AT SURGERY], THE AORTIC VALVE WAS EXPOSED. THERE WAS NO EVIDENCE OF ANY VEGETATIONS IN THE LEAFLET. THE VALVE HAD DEHISCED ALONG ITS APPROXIMATELY ONE-THIRD OF ITS CIRCUMFERENCE INVOLVING THE NON AND RIGHT CORONARY CUSP. THE VALVE WAS CAREFULLY EXCISED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX 5L1973

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R