BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1060314 · Received June 13, 2008

    Report

    Report Number
    2024168-2008-00485
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS AS PER SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THEREFORE, NO COMPLAINT ROUTE CAUSE CAN BE IDENTIFIED. IT IS POSSIBLE THAT THE STENT GRAFT WAS NOT PLACED CENTRALLY OVER THE PERFORATION OR THAT THE STENT GRAFT CHOSEN WAS NOT LONG ENOUGH TO COVER THE PERFORATION. ALSO POSSIBLY THE PERFORATION GREW IN SIZE DURING THE DEPLOYMENT OF THE STENT GRAFT. NO DEVICE MALFUNCTION CAN BE DETERMINED DUE TO THE LACK OF PROCEDURE AND PT INFO AND THE LACK OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: PERFORATION NOT SEALED IMMEDIATELY/DEATH. DEVICE ISSUE: NONE. IT WAS REPORTED THAT A PERFORATION WAS CAUSED BY THE DEPLOYMENT OF ANOTHER COMPANY'S STENT, CAUSING A PERICARDIAL BLEED. THE GRAFTMASTER WAS USED TO SEAL THE PERFORATION SUCCESSFULLY; HOWEVER, IT DID NOT SEAL IMMEDIATELY. PERICARDIOCENTISIS WAS PERFORMED. THE VESSEL SPASMED AND CLOTTED, HEPARIN WAS REVERSED AND THE VESSEL WAS ABLE TO BE REOPENED WITH AN ASPIRATION CATHETER. NITROGLYCERIN WAS USED TO TREAT THE SPASM. THE PT WAS REMOVED FROM THE CATH LAB; HOWEVER, TWELVE HRS POST PROCEDURE, THE PT EXPERIENCED AN MI AND EXPIRED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 410735

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death