BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3881969 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03909
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BLEEDING ANEURYSM/RETROPERITONEAL HEMATOMA IN THE SUPERIOR MESENTERIC ARTERY. IT SHOULD BE NOTED THAT THE GRAFTMASTER RX INSTRUCTIONS FOR USE (IFU) STATES: THE GRAFTMASTER RX IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. THE EFFECTIVENESS OF THIS DEVICE FOR THIS USE HAS NOT BEEN DEMONSTRATED. LONG-TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. IN THIS CASE, IT IS UNKNOWN IF THE USE OF THE GRAFTMASTER OUTSIDE THE INDICATION FOR USE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BLEEDING ANEURYSM/RETROPERITONEAL HEMATOMA IN THE SUPERIOR MESENTERIC ARTERY. THE 3.5 X 26 MM GRAFTMASTER STENT WAS ADVANCED, BUT COULD NOT CROSS TO THE ANEURYSM DUE TO THE ANATOMY. THE PATIENT WAS SENT TO SURGERY FOR SUCCESSFUL TREATMENT OF THE HEMATOMA, AND DISCHARGED WITH A GOOD OUTCOME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358955 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R