BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3900447 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04175
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE STENT REMAINS IN THE ANATOMY. THE GRAFTMASTER WAS USED FOR TREATMENT OF A RENAL ARTERY ANEURYSM. 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. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OTW GRAFTMASTER WAS USED IN A THIRD (3) LEVEL RENAL ARTERY ANEURYSM PROCEDURE OF THE LEFT KIDNEY AND WAS INFLATED TO 14 ATMOSPHERE (ATM) AND THE STENT WAS SUCCESSFULLY IMPLANTED WITHOUT REPORTED ISSUE. THE PATIENT DID NOT DIE AND WAS NOTED TO BE IN STABLE CONDITION POST-PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE PATIENT EFFECT OR DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT INFORMATION RECEIVED VIA PROCEDURE NOTES STATES, THE 3.5 X 16 MM GRAFTMASTER WAS DEPLOYED AND POST DEPLOYMENT VESSEL SPASM WAS NOTED AND TREATED WITH 400 MICROGRAMS OF NITROGLYCERIN DIRECTLY INTO THE POLAR BRANCH. HOWEVER, THIS DID NOT HELP TO RESOLVE THE SPASM. THE PROCEDURE WAS TERMINATED AND THERE WAS NO COMPLICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377685 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 703939

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention