BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1253186 · Received December 5, 2008

    Report

    Report Number
    2024168-2008-01313
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    May 4, 2007
    Report Date
    November 5, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - REQUIRED INTERVENTION - PERMANENT DAMAGE. REPORTING RATIONALE: FAILURE TO CROSS RESULTING IN DEPLOYMENT IN AN UNINTENDED SITE AND USE OF SECOND DEVICE. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE PATIENT CAME IN 18 HOURS AFTER THE ONSET OF A MYOCARDIAL INFARCTION (MI) AND ALSO PRESENTED WITH THROMBUS. A THROMBECTOMY WAS PERFORMED WITH ANOTHER COMPANY'S CATHETER AND ANOTHER COMPANY'S BARE METAL STENT WAS PLACED. A PERFORATION WAS NOTED; HOWEVER, IT WAS UNSURE WHETHER THE CATHETER OR THE STENT CAUSED IT. A 4.0 X 16 MM GRAFTMASTER WAS ATTEMPTED TO TREAT THE PERFORATION; HOWEVER, IT COULD NOT CROSS THE HEAVY CALCIUM, AND TO SAVE TIME, IT WAS DEPLOYED AT THE PROXIMAL PART OF THE PERFORATION. A 4.0 X 12 MM GRAFTMASTER WAS CROSSED THROUGH THE 4.0 X 16 MM AND SEALED THE PERFORATION. THE EXISTING THROMBOSIS WAS THOUGHT TO BE TREATED TO THE BEST OF THEIR ABILITY AND THE PROCEDURE WAS CONCLUDED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention| S JOSTENT GRAFTMASTER 4.0 X 12 MM