BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1831547 · Received September 10, 2010

    Report

    Report Number
    2015691-2010-14045
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 11, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS LEARNED FROM A RETURNED IDC RECEIVED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), A COPY OF THE OPERATIVE REPORT WAS RECEIVED ON 08/13/2010, HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED. MORE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE ON 09/10/2010, HOWEVER, THE REPORTED CAUSE OF DEATH HAS YET TO BE CONFIRMED. ADDITIONAL INFORMATION IS ANTICIPATED. THERE HAS BEEN NO ALLEGATIONS OF A MALFUCTION OF THE DEVICE RESULTING IN SERIOUS INJURY OR DEATH. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE CAUSE OF DEATH WAS PROVIDED AS "LARGE RIGHT CEREBRAL INFARCT". PER THE PATIENT'S DISCHARGE SUMMARY PROVIDED, "ON THE MORNING OF (B)(6), THE PATIENT WANTED TO GO TO THE BATHROOM AND HER HUSBAND HELPED HER TO TAKE HER TO THE BATHROOM WHEN SHE COLLAPSED." A FOLLOW-UP "MRI IF THE BRAIN SHOWED LARGE RIGHT CEREBRAL INFARCT WITH MASS EFFECT AS WELL AS UNCAL HERNIATION ON THE RIGHT SIDE. HER MR ANGIOGRAM SHOWED ABSENT FLOW IN THE RIGHT MIDDLE CEREBRAL ARTERY AS WELL AS DIMINISHED FLOW OF THE RIGHT ANTERIOR CEREBRAL ARTERY WHICH CORRESPONDED WITH TERRITORIES OF THE PATIENT'S RIGHT CEREBRAL INFARCT. A TEE WAS INITIALLY PLANNED, BUT DUE TO THE PATIENT'S UNSTABLE CONDITION WE WERE NOT ABLE TO PERFORM TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT HAD AGONAL BREATHING AND WAS SEEN IN CONSULTATION BY DR.(B)(6) FROM PULMONARY DEPARTMENT, AND HE MADE AN EMERGENCY INTUBATION FOR THE PATIENT. THE PATIENT WAS ALSO SEEN IN CONSULTATION BY NEUROSURGEON, DR. (B)(6) AND BECAUSE OF THE LARGE RIGHT HEMISPHERIC STROKE WITH HERNIATION, HE DID NOT RECOMMEND ANY SURGICAL INTERVENTION AND ONLY RECOMMENDED SUPPORTIVE CARE AND PALLIATIVE CARE." THE PATIENT EXIRED ON THE MORNING OF (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.40 MONTHS. IT WAS NOTED ON AN IMPLANT DATA CARD (IDC) RETURNED BY THE PATIENT'S HUSBAND THAT SHE EXPIRED DUE TO A "MASSIVE STROKE". ON 08/13/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH COULD NOT BE CONFIRMED. PER THE OPERATIVE REPORT OF (B)(6)2010, THE PATIENT WAS ADMITTED FOR MITRAL VALVE REPLACEMENT FOR MITRAL REGURGITATION. THE VALVE WAS IMPLANTED SUCCESSFULLY. "THE PATIENT WAS TRANSPORTED HEMODYNAMICALLY STABLE TO OPEN HEART RECOVERY."

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED CKMB RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FROM ONE PATIENT'S SAMPLE. THE CKMB RESULT WAS NOT REPORTED OUT OF THE LAB. UPON REPEAT TESTING THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09K2438

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death