BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1033915 · Received April 24, 2008

    Report

    Report Number
    2024168-2008-00340
    Event Type
    Death
    Date Received
    April 24, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, IT CAN BE ASSUMED THAT THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR AS PER MANUFACTURING SPECIFICATIONS. IT IS REPORTED THAT THERE WERE COMPLICATIONS, BUT THE COMPLICATIONS WERE NOT DEVICE RELATED. THE PERFORATION WAS CAUSED BY AN UNKNOWN BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO INFORMATION PROVIDED REGARDING THE RELATIONSHIP BETWEEN THE PATIENT DEATH AND THE STENT GRAFT USED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO DEVICE MALFUNCTION CAN BE IDENTIFIED AND NO JUDGEMENT CAN BE MADE AS TO THE ROOT CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH, REPORTING RATIONALE: DEATH, DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS BEING USED TO COVER A PERFORATION. THE PROCEDURE WAS ORIGINALLY A BARE METAL STENT (UNKNOWN BARE METAL STENT) CASE THAT RESULTED IN A PERFORATION IN THE RIGHT CORONARY ARTERY (RCA). THE GRAFTMASTER WAS DEPLOYED WITHOUT AN ISSUE; HOWEVER, THE PATIENT DIED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 507856

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death