BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1818015 · Received August 20, 2010

    Report

    Report Number
    2024168-2010-01721
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ABBOTT VASCULAR THERAPIES, ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER OTW CORONARY DILATATION CATHETER (PART 1009439-12, LOT 0031961) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE 2 ISSUE: LOOSE STENT. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE BALLOON WAS PLACED AND INFLATED IN THE RIGHT CORONARY ARTERY (RCA) FOR ONE MINUTE AT 18 ATMS. WHEN NEGATIVE PRESSURE WAS APPLIED, BLOOD WAS SEEN COMING BACK INTO THE INFLATION DEVICE. AN ANGIOGRAM SHOWED A PERFORATION IN THE SAPHENOUS VEIN GRAFT, NOT IN THE RCA WHERE THE BALLOON HAD BEEN INFLATED; THEREFORE, IT WAS SUSPECTED THAT THERE WAS A SHAFT RUPTURE. A GRAFTMASTER STENT WAS ADVANCED TO TREAT THE PERFORATION. THE PHYSICIAN DID NOT FEEL THE GRAFTMASTER WAS IN THE CORRECT LOCATION. AN ATTEMPT WAS MADE TO PULL BACK ON THE DEVICE, BUT THE STENT APPEARED TO BE MOVING ON THE BALLOON. THEREFORE, THE STENT WAS DEPLOYED AT THIS LOCATION, WHICH DID SUCCESSFULLY SEAL THE PERFORATION. THERE WERE NO ADD'L PT EFFECTS. THE PT OUTCOME WAS GOOD AND THE PT WAS RELEASED 2 DAYS POST-PROCEDURE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR THERAPIES, ABBOTT VASCULAR GERMANY NA 515369

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR VOYAGER OTW CORONARY DILATATION CATHETER| (PART 1009439-12, LOT 0031961)