BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2032790 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02111
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 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 INVESTIGATION. 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. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR LEAKS FOR THIS LOT. 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 DURING THE PROCEDURE IN THE PROXIMAL CIRCUMFLEX ARTERY, A JOSTENT GRAFTMASTER STENT GRAFT WAS DEPLOYED FOR TREATMENT OF A PERFORATION CAUSED BY A NON-ABBOTT DILATATION CATHETER. AFTER DEPLOYMENT OF THE STENT GRAFT, DEPLOYMENT OF A 3X8 VISION STENT WAS REQUIRED TO COMPLETELY SEAL THE PERFORATION DUE TO A PERSISTENT LEAK AT THE DISTAL EDGE OF THE STENT GRAFT. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 645954

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention QUANTUM DILATATION CATHETER