BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2113254 · Received June 3, 2011

    Report

    Report Number
    2015691-2011-15679
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - POSTERIOR ARTERY BLEEDING. .DEVICE NOT RETURNED. .ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SUBJECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION REVEALS NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING 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 WS LEARNED THAT THE EDWARDS' VALVE WAS EXPLANTED AT IMPLANT, AND REPLACED WITH ANOTHER SAME MODEL SMALLER SIZE EDWARDS' BIOPROSTHESIS. PER OPERATIVE REPORT, THE VALVE WAS EXPLANTED TO REPAIR BLEEDING FROM A TEAR BEHIND THE PULMONARY ARTERY. OPERATIVE REPORT STATES, "VALVE WAS LOWERED IN PLACE AND SUTURES WERE ALL TIED. ADEQUATE VALVE SEATING WAS THEN NOTED BY VISUAL INSPECTION BOTH ABOVE AND BELOW THE ANNULUS. VALVE LEAFLET MOTION WAS NOTED UNIMPEDED...THE HEART AND BOTH VENTS WERE REMOVED. BRISK LIGHT BLEEDING WAS NOTED FROM BEHIND THE PULMONARY ARTERY. THIS WAS INITIALLY REPAIRED WITH NUMBER OF PLEDGETED SUTURES. HOWEVER, THIS CONTINUED AND THERE WAS A PROBLEM AT THE LEVEL OF THE ANNULUS OF THE AORTIC VALVE. WE RE-ARRESTED THE HEART WIT CARDIOPLEGIA FOR SECOND TIME OF 51 MINUTES. WE SUBSEQUENTLY OPENED THE ASCENDING AORTA AND WE SAW A SMALL AREA OF TEAR BENEATH THE AORTIC ANNULUS AND ATTEMPTED TO PLACE PLEDGETED SUTURE IN THIS AREA. NO OTHER PROBLEMS WERE NOTED; THEREFORE THE ASCENDING AORTA WAS CLOSED HOWEVER, ONCE AGAIN WHEN TAKING THE CLAMP OFF, BRISK BLEEDING WAS NOTED IN THE SAME AREA POSTERIOR TO THE PULMONARY ARTERY. FOLLOWING THIS, WE DECIDED TO RE-ARREST...EXCISED THE PREVIOUS 23 VALVE, SAW A MORE SIGNIFICANT TEAR AT 9 O'CLOCK BY SURGEON'S VIEW, WHICH CORRESPONDED TO JUST BENEATH THE LEFT MAIN. THIS WAS BELOW THE ANNULUS WHERE THE EXCESSIVE DÉBRIDEMENT OF CALCIFICATION OCCURED. WE DECIDED TO DOWN SIZE TO A 21 VALVE AND PLACED THE PLEDGETED SUTURES DOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 R-10H2062

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R