BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1880681 · Received October 25, 2010

    Report

    Report Number
    2015691-2010-14245
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) = SEATING ISSUE.DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS. THE PATIENT ALSO HAD ANOTHER VALVE IMPLANTED; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. ON (B)(6)2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SEATING ISSUE. FURTHERMORE, THE DEVICE HAS BEEN DISASSOCIATED FROM THE EVENT. ON 10/13/2010, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. PER THE OP REPORT: "A 27-MM VALVE WAS SUTURED WITH HORIZONTALLY MATTRESSED SUTURES EVERTING. IT DID NOT SEAT WELL AND THEREFORE IT WAS REMOVED. AN ATTEMPT WAS MADE TO RE-PLACE THAT VALVE; HOWEVER, AGAIN THIS TIME ANTERIORLY, THE STRUT WOULD NOT CLEAR THE SUBVALVULAR APPARATUS AND THEREFORE THIS WAS REMOVED AND A 25-MM VALVE INSERTED WITH THE EVERTING HORIZONTALLY MATTRESSED 2-0 ETHIBOUND SUTURES." THE OP REPORT ENDED STATING THAT THE PATIENT EXPERIENCED SIGNIFICANT HEMMORRHAGE. THE PATIENT BECAME HYPOTENSIVE AND WAS NOT RESUSCITABLE; PATIENT EXPIRED IN THE OPERATING ROOM..

    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-10B0326

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R