BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4232970 · Received November 6, 2014

    Report

    Report Number
    2015691-2014-02623
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    October 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: ALTHOUGH THERE HAVE BEEN ATTEMPTS, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. STENOSIS OF AN IMPLANTED VALVE, LIKE REGURGITATION, MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION. THERE ARE CASES OF SVD THAT RESULT IN A COMBINATION OF REGURGITATION AND STENOSIS. IN THIS CASE, WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. 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 THIS AORTIC VALVE WAS EXPLANTED AFTER NINE (9) YEARS, ELEVEN (11) MONTHS DUE TO PROSTHETIC VALVE DEGENERATION WITH STENOSIS AND INSUFFICIENCY. THIS WAS REPLACED WITH A 23MM PERICARDIAL BIOPROSTHESIS. THE CHEST REMAINED OPEN DUE TO COMPLICATIONS AND THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT EXPERIENCED "CONTINUED CARDIAC DYSFUNCTION" AND AN ATTEMPT TO REVASCULARIZE THE RCA WAS UNSUCCESSFUL. CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715738 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R ATENOLOL| ASPIRIN| LISINOPRIL| ATORVASTATIN| LASIX| COUMADIN| METFORMIN| LYRICA