BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2151947 · Received July 7, 2011

    Report

    Report Number
    2015691-2011-15837
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION OR QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS THE REASON FOR EXPLANT, OPERATIVE REPORT, AND DEVICE STATUS FOR RETURN; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF 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 PULMONARY BIOPROSTHESIS WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 MONTHS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED DESPITE MULTIPLE FLLOW-UP ATTEMPTS WITH THE HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO PULMONARY REGURGITATION DUE TO PARAPROSTHETIC LEAK. OPERATIVE FINDINGS INDICATE: " ON THE PULMONARY VALVE, THE ANTERIOR SUTURES USED TO FIX THE VALVE ANTERIORLY HAD APPEARED TO HAVE WORKED THEIR WAY THROUGH THE PATCH AND WAS SEEN IN THE ANTERIOR SEWING RING. IN ADDITION, THERE WERE A NUMBER OF AREAS OF THROMBUS ON THE VALVE , AND ALTHOUGH I THINK THE MOST LIKELY DUE TO THE TURBULENCE SECONDARY TO THE LEAK, IT WAS NOT POSSIBLE TO EXCLUDE ENDOCARDITIS AS AN ETIOLOGY FOR THE LEAK". THE SURGEON INDICATED THAT THE REASON FOR EXPLANTING IS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-09M2788

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R