BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3913930 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04360
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 31, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: GUIDE WIRE: PROWATER, WIGGLE. (B)(4) - INDICATION FOR USE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES: THE JOSTENT GRAFTMASTER 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE GRAFTMASTER REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CIRCUMFLEX (LCX) THROMBOSED ANEURYSM. A PROWATER GUIDE WIRE WAS ADVANCED AND AN ASPIRATION THROMBECTOMY WAS PERFORMED WITH A NON-ABBOTT DEVICE WHICH WAS INEFFECTIVE. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE ANEURYSM WAS FILLED WITH THROMBUS. A 4.0 X 26 MM GRAFTMASTER COULD NOT CROSS THE LESION AND WHEN REMOVING THE STENT DELIVERY SYSTEM, IT COULD NOT BE PULLED INTO THE GUIDING CATHETER AND THE TWO DEVICES WERE REMOVED TOGETHER. A NON-ABBOTT BALLOON WAS INFLATED IN THE LESION. THE PROWATER WAS EXCHANGED FOR A WIGGLE GUIDE WIRE AND A 3.5 X 26 MM GRAFTMASTER COULD NOT BE ADVANCED THROUGH AN 8F GUIDELINER AND THE DEVICES WERE REMOVED TOGETHER. THEN A 4.0 X 16 MM GRAFTMASTER WAS DEPLOYED AT 10 ATMOSPHERES FOR 30 SECONDS. A 3.0 X 26 GRAFTMASTER WAS ADVANCED TO THE LESION; HOWEVER, THE 4.0 X 16 MM GRAFTMASTER HAD MIGRATED PROXIMALLY AND WAS UNDER DEPLOYED SO THE 3.0 X 26 GRAFTMASTER WAS REMOVED FROM THE ANATOMY AND TWO NON-ABBOTT BALLOON CATHETERS WERE USED FOR POST DILATATION OF THE 4.0 X 16 MM GRAFTMASTER. A 4.5 X 16 MM GRAFTMASTER WAS DEPLOYED PROXIMALLY OVERLAPPING THE 4.0 X 16 MM GRAFTMASTER AND A NON-ABBOTT STENT WAS DEPLOYED IN THE DISTAL PART OF THE LCX OVERLAPPING THE 4.0 X 16 MM GRAFTMASTER. POST DILATATION WAS PERFORMED IN THE OVERLAPPING SECTIONS WITH A NON-ABBOTT 5.0 MM BALLOON TO COMPLETE THE PROCEDURE. THE THROMBUS AND MIGRATED DISTALLY SO A NON-ABBOTT STENT WAS DEPLOYED IN THE DISTAL LCX OVERLAPPING THE 4.0 X 16 MM GRAFTMASTER. IVUS WAS PERFORMED TO SHOW ALL STENTS WERE WELL APPOSED AND EXPANDED. THE RESULTS WERE EXCELLENT WITH A TIMI 3 FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389580 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 680246

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention