BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1962101 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00348
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INCORRECT ANATOMY. FAILURE TO SEAL THE PERFORATION (THE REPORTED LEAK) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, STENT GRAFT FOIL DAMAGE, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PERFORATION OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS (SDS) ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT. THE STENT REMAINS IN THE ANATOMY, AND THE PRODUCT WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. IN THIS CASE, IT IS POSSIBLE THAT THE STENT WAS NOT POSITIONED CORRECTLY IN THE ANATOMY TO PROPERLY SEAL THE PERFORATION. HOWEVER AS THIS CANNOT BE CONFIRMED, A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION CANNOT BE DETERMINED. ADDITIONAL TREATMENT WAS USED TO HELP SEAL THE PERFORATION. IT WAS REPORTED THE GRAFTMASTER WAS USED TO TREAT A PERFORATION IN THE RIGHT ILIAC ARTERY. IT SHOULD BE NOTED THE GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES: THE JOSTENT GRAFTMASTER 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 ACUTE CORONARY ARTERY PERFORATIONS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS CASE, ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL AND THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED IN THE RIGHT ILIAC TO TREAT A PERFORATION CAUSED BY A NON-ABBOTT DEVICE. THE STENT WAS IMPLANTED, HOWEVER DID NOT COMPLETELY SEAL THE PERFORATION. ADDITIONAL BALLOON INFLATIONS WERE PERFORMED WITH THE STENT DELIVERY SYSTEM BALLOON TO COMPLETELY STOP THE PERFORATION LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 596935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention