BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3051491 · Received April 10, 2013

    Report

    Report Number
    2015691-2013-19787
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THE EXPLANT CANNOT BE CONFIRMED, IT APPEARS THAT THE PATIENT'S AORTIC STENOSIS WAS LIKELY CAUSED BY THE CALCIFIED DEVICE. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. THE PATIENT'S POSTOPERATIVE COURSE WAS ALSO COMPLICATED BY RESPIRATORY FAILURE, RENAL AND MULTISYSTEM ORGAN FAILURE. THERE HAVE NOT BEEN ANY ALLEGATIONS THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS AND 4 MONTHS DUE TO SEVERE AORTIC STENOSIS, AS A RESULT OF STRUCTURAL VALVE DETERIORATION. ACCORDING TO THE OP REPORT, THE PROSTHETIC VALVE HAD VERY CALCIFIED AND STIFF LEAFLETS THAT WERE ESSENTIALLY IMMOBILE. THE VALVE WAS EXCISED FROM THE ANNULUS WITH THE OUTER LAYER OF FABRIC KEPT IN PLACE AS MUCH AS POSSIBLE. THE AORTIC ROOT WAS NOTED TO BE EXTREMELY SMALL; THEREFORE, ROOT ENLARGEMENT WAS PERFORMED. THE AORTIC VALVE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHESIS. POSTOP ECHO SHOWED NO RESIDUAL INTRACARDIAC AIR AND A NORMALLY FUNCTIONING PROSTHETIC VALVE. THE PATIENT WAS THEN TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. UNFORTUNATELY, THE PATIENT'S POSTOPERATIVE COURSE WAS COMPLICATED. PER THE EXPIRATION SUMMARY, THE PATIENT BECAME HYPOXIC REQUIRING MULTIPLE INOTROPES POSTOP. THE PATIENT HAD EVIDENCE OF SIGNIFICANT PULMONARY EDEMA; HOWEVER, IT WAS FELT THAT THIS COULD BE MANAGED MEDICALLY. OVER THE NEXT 24-HOURS, THE PATIENT BECAME MORE UNSTABLE. ECHO DID NO SHOW EVIDENCE OF PERICARDIAL EFFUSION. THE PATIENT'S PULMONARY STATUS REMAINED VERY POOR AND CONTINUED TO REQUIRE 100% OXYGEN WITH SIGNIFICANT PULMONARY EDEMA. LATE ON POD #1, THE PATIENT DEVELOPED PROGRESSIVE ACIDOSIS DESPITE BEING ON CRRT. THROUGHOUT THE NIGHT THE PATIENT WAS VERY UNSTABLE AND HYPOTENSIVE DESPITE MULTIPLE INOTROPES AND MAXIMUM VENTILATORY SUPPORT. DUE TO THESE FACTORS, THE FAMILY DECIDED WITHDRAW COMFORT CARE. THE PATIENT WAS NOTED TO ESSENTIALLY HAVING A POOR CHANCE OF RECOVERY GIVEN HER PROGRESSIVE MULTISYSTEM ORGAN FAILURE. SHE WAS PRONOUNCED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148698 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R