BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3864963 · Received June 10, 2014

    Report

    Report Number
    2015691-2014-01341
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THERE HAVE BEEN ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. STENOSIS OF AN IMPLANTED VALVE MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION (SVD). IN THESE CASES, IT CAUSES THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE AND CAN BE, DEPENDING ON THE SEVERITY, AN INDICATION FOR VALVE REPLACEMENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN AORTIC VALVE EXPLANT AFTER AN IMPLANT DURATION OF THIRTEEN (13) YEARS, TEN (10) MONTHS DUE TO STENOSIS AND PROSTHETIC VALVE DYSFUNCTION. THIS WAS REPLACED WITH A 23 MM PERICARDIAL BIOPROSTHESIS. WHILE WEANING FROM CARDIOPULMONARY BYPASS (CPB), THE PATIENT DEVELOPED SEVERE PULMONARY HYPERTENSION. TEE SHOWED DILATED RIGHT-SIDED CHAMBERS. PATIENT REQUIRED MULTIPLE ATTEMPTS AT WEANING TO SUCCESSFULLY DISCONTINUE CPB. ONCE STABLE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN CRITICAL CONDITION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH A PERICARDIAL BIOPROSTHESIS. OFF BYPASS, CORONARY ARTERY BYPASS SURGERY WAS DONE TO THE LAD AND RIGHT CORONARY ARTERY. INTRAAORTIC BALLOON PUMP WAS PLACED BECAUSE OF SIGNIFICANT PULMONARY HYPERTENSION WITH NO CARDIAC OUTPUT. THE PATIENT EVENTUALLY REQUIRED DIALYSIS; HOWEVER, SHE DEVELOPED PROGRESSIVE RESPIRATORY INSUFFICIENCY AND EVENTUALLY EXPIRED FROM RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339554 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R