BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2030028 · Received March 25, 2011

    Report

    Report Number
    2015691-2011-15092
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    November 3, 2010
    Report Date
    February 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DHR IS IN PROGRESS. WE HAVE BEEN UNSUCCESSFUL, DESPITE REPEATED ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE INFECTION AND POSSIBLY RETURN OF THE DEVICE. HOWEVER, WE DID RECEIVE THE OPERATIVE REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORT OF ENDOCARDITIS. THE HEALTH CARE PROVIDER INDICATED THE DEVICE WAS EXPLANTED DUE TO PROSTHETIC VALVE DEHISCENCE MOST LIKELY DUE TO PROSTHETIC VALVE ENDOCARDITIS. ACCORDING TO THE OPERATIVE REPORT, CULTURES AND GRAM STAINS WERE SENT TO PATHOLOGY; BUT THE PATHOLOGY REPORT HAS NOT BEEN PROVIDED. THEREFORE, THE TYPE AND SOURCE OF THE INFECTION HAVE NOT BENN IDENTIFIED. WITHOUT ADDITIONAL INFORMATION REGARDING THE TYPE OF INFECTION, WE ARE UNABLE TO CONTINUE OUR INVESTIGATION INTO THE ROOT CAUSE OF THE DEHISCENCE AND EXPLANT OF THIS DEVICE. THIS EXPLANT OCCURRED AT SIX MONTHS POST IMPLANT. 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, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY SIX MONTHS DUE TO PATIENT RELATED FACTORS AND NOT RELATED TO A DEVICE MALFUNCTION. PER THE OPERATIVE REPORT: THE PREOPERATIVE DIAGNOSIS STATED PROSTHETIC VALVE DEHISCENCE MOST LIKELY PROSTHETIC VALVE ENDOCARDITIS. THE VALVE APPEARED TO BE DEHISCED FROM A CHRONIC INDOLENT INFECTION THOUGH THERE WERE NO VEGETATIONS. AFTER INDUCTION OF ANESTHESIA, THE PATIENT WAS PREPPED AND DRAPED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED NORMAL LEFT VENTRICULAR FUNCTION. THERE WAS A 3+ AMOUNT OF INSUFFICIENCY IN THE MITRAL VALVE. THERE WAS NO STENOSIS IN THE MITRAL VALVE... THE PROSTHETIC VALVE WAS EXCISED... [REPLACEMENT DEVICE SUTURED AND IMPLANTED]. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY AND NO INOTROPES WERE USED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED THE MITRAL PROSTHESIS TO BE WELL SEATED WITH 0 AMOUNT OF INSUFFICIENCY. THE LEFT VENTRICLE MOVED NORMALLY. THE RIGHT VENTRICLE WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09L2621

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R