BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3813601 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03081
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. IT SHOULD BE NOTED THAT THE RX GRAFTMASTER 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 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANEURYSM IN A SAPHENOUS VEIN GRAFT OF AN OBTUSE MARGINAL ARTERY. A 4.0 X 16 MM RX GRAFTMASTER WAS DEPLOYED AT 10 ATMOSPHERES; HOWEVER, THERE WAS SUBOPTIMAL EXPANSION AND AN ENDOLEAK WAS OBSERVED. A 6.0 X 20 MM NON-ABBOTT BALLOON CATHETER WAS USED TO FURTHER EXPAND THE STENT AND THERE WAS SUCCESSFUL EXCLUSION OF THE ANEURYSM BUT THE PROXIMAL END OF THE STENT WAS STILL INADEQUATELY APPOSED. A 7.0 X 20 MM VIATRAC WAS SUCCESSFULLY USED TO EXPAND THE PROXIMAL END OF THE STENT TO COMPLETE THE PROCEDURE. 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
    291111 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4030441

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention