BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1960619 · Received January 13, 2011

    Report

    Report Number
    2015691-2011-14669
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    August 27, 2010
    Report Date
    December 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION. THERE APPEARS TO BE PATIENT/ANATOMIC AND PROCEDURAL RELATED FACTORS THAT CAUSE OR CONTRIBUTED TO THIS EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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 AT THE TIME OF IMPLANT. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A PERIVALVULAR LEAK. ACCORDING TO THE OPERATIVE REPORT, THE AORTA WAS OPENED TRANSVERSELY AND A HEAVILY CALCIFIED BICUSPID AORTIC VALVE WAS RESECTED. THE ANNULUS REQUIRED EXTENSIVE DEBRIDEMENT TO GET BACK TO SOFT TISSUE. THIRTEEN 2-0 ETHIBOND PLEDGETED SUTURES WERE PLACED ON THE VENTRICULAR SIDE, BROUGHT SEQUENTIALLY THROUGH A 23 MM VALVE. THE SUTURES WERE TIED DOWN. THERE WERE NO PERIVALVULAR LEAKS. AORTOTOMY WAS CLOSED. DE-AIRING WAS CARRIED OUT. CROSS CLAMP WAS REMOVED. PATIENT WAS WARMED TO 36 DEGREES CELSIUS, HOWEVER AS WE WERE WARMING, THE ECHO REVEALED EVIDENCE OF AT LEAST 2+ PERIVALVULAR AORTIC INSUFFICIENCY. I DID NOT FEEL COMFORTABLE LEAVING THIS AND SO THE HEART WAS REARRESTED AS THE PATIENT WAS RECOOLED. THE AORTOTOMY WAS ONCE AGAIN OPENED AND THE VALVE WAS INSPECTED. THE LEAFLETS WERE INTACT BUT THERE WAS A PERIVALVULAR LEAK ALONG THE RIGHT CORONARY ARTERY THAT I DID NOT FEEL COULD BE TREATED WITH JUST ISOLATED REPAIR STITCHES. THE VALVE WAS THEN EXCISED. ALL PLEDGET AND GRAFT MATERIAL WERE REMOVED AND A NEW VALVE WAS CHOSEN. ONCE AGAIN THIRTEEN 2-0 ETHIBOND PLEDGETED SUTURES WERE PLACED ON THE VENTRICULAR SIDE, BROUGHT SEQUENTIALLY THROUGH A 23 MM VALVE. SUTURES WERE AGAIN TIED DOWN. THERE WERE NO PERIVALVULAR LEAKS. POST PUMP VENTRICULAR FUNCTION WAS GOOD AND THE ECHO SHOWED NO AORTIC INSUFFICIENCY. FURTHERMORE, THERE HAVE BEEN NO ALLEGATIONS OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10E1222

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention