BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 6132958 · Received November 29, 2016

    Report

    Report Number
    2015691-2016-03515
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 7, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. FAILURE OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS, NON-CALCIFIC DEGENERATION AND/OR ENDOCARDITIS. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS VALVE-IN-VALVE PROCEDURE WAS RECEIVED AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. THIS DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS RECEIVED INFORMATION THAT A 23 MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE WITH A NON-EDWARDS DEVICE AFTER AN UNKNOWN IMPLANT DURATION AND DUE TO UNKNOWN REASONS. THE PATIENT THEN PRESENTED WITH WORSENING SHORTNESS OF BREATH AND CHEST PAIN AND WAS FOUND TO HAVE SIGNIFICANT CORONARY ARTERY DISEASE, SEVERE AORTIC STENOSIS, AND ACUTE-ON-CHRONIC SYSTOLIC HEART FAILURE WITH AN EF OF 35%. THE NON-EDWARDS VALVE AND THE 23 MM PERICARDIAL AORTIC VALVE WERE EXPLANTED AND REPLACED WITH A 25 MM PERICARDIAL AORTIC VALVE. THE IMPLANT DURATION OF THE 23 MM PERICARDIAL AORTIC VALVE WAS ELEVEN (11) YEARS, TEN MONTHS (10), AND ELEVEN (11) DAYS. THE PATIENT ALSO UNDERWENT CABG X2 DURING THIS SURGERY. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS LAST REPORTED TO BE IN RECOVERY POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782701 CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 280023MM

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R