BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2031965 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15103
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO EVIDENCE OF AN EDWARDS' DEVICE QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY. ACCORDING TO THE OPERATIVE REPORT, THIS PATIENT HAD UNDERGONE AORTIC VALVE REPLACEMENT AND HAD A HISTORY OF CORONARY ARTERY DISEASE WITH A STENTING OF THE LAD BACK IN 2001, WHICH HAD BECOME SYMPTOMATIC WITH DEVELOPMENT OF CONGESTIVE HEART FAILURE. CARDIAC WORKUP REVEALED A TIGHT LESION INVOLVING THE PROXIMAL PART OF THE LEFT ANTERIOR CORONARY ARTERY PROXIMAL TO THE STENT. THE RIGHT WAS A NON-DOMINANT SMALL VESSEL WITH 70% BLOCKAGE. INJECTION SHOWED MODERATE TO SEVERE AORTIC REGURGITATION. THE CAUSE OF THIS REGURGITATION WAS NOT CLEAR ON SURFACE ECHO. THE PATIENT HAD MILD AORTIC REGURGITATION. EJECTION FRACTION REPORTED TO BE 56%. BASED ON THESE FINDINGS, THE PATIENT WAS ADMITTED FOR REDO OPERATION. INTRA-OPERATIVE ECHO AGAIN SHOWED SOME DEGREE OF AORTIC REGURGITATION BUT THE CAUSE COULD NOT BE IDENTIFIED. THE HEART WAS MODERATELY ENLARGED DUE TO THE LEFT VENTRICULAR HYPERTROPHY. THE AORTIC BIOPROSTHESIS DID NOT SHOW ANY GROSS ABNORMALITIES. THE COLOR WAS YELLOWISH, WHICH IS COMMON AT THIS STAGE; HOWEVER, UPON INSPECTIONS THERE WAS NOT ANY EVIDENCE OF PARAVALVULAR LEAK. IT WAS NOTED THAT THE LEAK WAS PROBABLY CENTRAL; IT WAS POSSIBLE, DURING AORTOGRAPHY, THE CATHETER MIGHT HAVE ARTIFICIALLY KEPT THE OPENING OF THE VALVE BIGGER THAN USUAL AS A RESULT SHOWED MORE REGURGITATION. THE ASCENDING AORTA HAD NO OBVIOUS CALCIFICATION. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THE VALVE WAS EXAMINED BY ECHOCARDIOGRAPHY AND PROVED TO BE FUNCTIONING SATISFACTORILY WITH NO PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 R-07F1170

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention