BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3841492 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03484
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED INFLATION ISSUE AND DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU) INDICATIONS STATES: THE GRAFTMASTER RX IS A BALLOON-EXPANDABLE PRE-MOUNTED CORONARY STENT GRAFT FOR INTRALUMINAL CHRONIC PLACEMENT IN CORONARY ARTERIES OR AORTO-CORONARY BYPASS GRAFTS FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM, CORONARY BYPASS VEIN GRAFT ANEURYSM, ACUTE CORONARY ARTERY PERFORATION, ACUTE CORONARY ARTERY RUPTURE. ALSO THE IFU INSTRUCTS: NOTE THE PRODUCT USE BY DATE SPECIFIED ON THE PACKAGE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING AN UNSPECIFIED ARTERY ACCESS APPROACH DURING A PERIPHERAL ARTERY PROCEDURE THE 4.8 X 26 MM RX GRAFTMASTER STENT DELIVERY SYSTEM WAS USED AND AT SOME UNSPECIFIED POINT DURING THE PROCEDURE THE SDS SHAFT DETACHED INTO TWO PIECES AND THE DISTAL PORTION REMAINS IN THE PATIENT ANATOMY.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED VIA FOUR STILL FLUOROSCOPIC IMAGES AND REVIEWED BY AN ABBOTT SPECIALIST WHICH REVEALED THE DISTAL SHAFT SEPARATED FROM THE PARTIALLY INFLATED STENT AND SDS AND THESE COMPONENTS REMAINED IN THE VERTEBRAL ARTERY. COILING WAS PERFORMED TO COMPRESS THESE COMPONENTS ALONG THE VESSEL WALL AND THE BLOOD SUPPLY TO THE VERTEBRAL CYST WAS INTERRUPTED. THE SEPARATION OF THE COMPONENTS CAN BE CONFIRMED WITH THE IMAGES PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318318 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 2102541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other