BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1672720 · Received April 30, 2010

    Report

    Report Number
    9616290-2010-00005
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 6, 2010
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) (B) (4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NO REPORTED DEVICE MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURING RECORDS FOR THIS PRODUCT WERE REVIEWED, AND THERE WERE NO NON-CONFORMANCES. THE GRAFTMASTER (PART 12744-19, LOT# 588165) REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RETROPERITONEAL BLEED/DEATH. ONSET OF ADVERSE EVENT: POST PROCEDURE. IT WAS REPORTED THAT A PERFORATION OCCURRED DURING A ROTOBLATER PROCEDURE. TWO JOSTENT GRAFTMASTER STENTS WERE DEPLOYED SEALING THE PERFORATION SUCCESSFULLY. POST PROCEDURE, THE PT DEVELOPED A RETROPERITONEAL BLEED AND DIED. REPORTEDLY, CLINICAL OPINION INDICATES THAT THE BLEED AND DEATH ARE UNRELATED TO THE GRAFTMASTER STENTS. THOUGH REQUESTED, NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 636413

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death (PART 12744-19, LOT# 588165)| 3.0 X 19 MM JOSTENT GRAFTMASTER