BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1649542 · Received April 2, 2010

    Report

    Report Number
    2015691-2010-13032
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    January 8, 2010
    Report Date
    March 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (4). TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX), FOR THE OPERATIVE REPORT AND ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ON 04/29/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX), A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. THE OPERATIVE REPORT OF (B) (6) 2010 WAS ALSO PROVIDED, HOWEVER, THE CAUSE OF DEATH COULD NOT BE LEARNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF APPROXIMATELY 0.1 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE CAME IN WITH A 6.3 X 5.6 MM SUPRACLINOID ANEURYSM. CORDIS ENTERPRISE STENT WAS ACCESSED WITH A CORDIS PROWLER 14 MICROCATHETER. AS THE FIRST PRESIDIO 6X26 MM MICROCOIL WAS SUCCESSFULLY PLACED, THE SECOND COIL, DELTAPAQ 2X6MM MICROCOIL PLACEMENT COULDN'T ADVANCE OUT OF THE MICROCATHETER. IT APPEARED THAT THE COIL WAS WRAPPING AROUND THE STENT. AFTER THIS OBSERVATION, THE COIL WAS PULLED BACK INTO THE MICROCATHETER AND RE-DEPLOYED THE SECOND TIME. THE COIL DEPLOYED IN THE SAME LOCATION. AT THIS POINT, THE PHYSICIAN DID A "RUN" AND EXTRAVASATION WAS NOTED. IT WAS APPARENT THAT THE ANEURYSM HAD RUPTURED. THE COIL WAS REMOVED AND REPLACED WITH 3 DELTAPLUSH MICROCOILS. ANOTHER RUN WAS COMPLETED WITH NO EVIDENCE OF BLEEDING. FOLLOW UP REPORT INDICATED THAT PROLONGED HOSPITALIZATION MAY BE REQUIRED DUE TO POSSIBILITY OF VASOSPASM. NO ADDITIONAL MEDICATIONS WAS PRESCRIBED PER RECEIVED REPORT. THE PATIENT WAS DOING FINE AND SEEMED TO BE MOVING ALL EXTREMITIES.

    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-08L2440

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death