BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2034012 · Received March 30, 2011

    Report

    Report Number
    2024168-2011-02164
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    August 5, 2009
    Report Date
    August 7, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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. THE GRAFTMASTER 3.0 X 12 MM IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SAPHENOUS VEIN GRAFT PERFORATION OCCURRED DURING THE USE OF A NON-ABBOTT BALLOON. THE 3.0 X 16 MM GRAFTMASTER WAS IMPLANTED AT 16 ATMOSPHERES, BUT DID NOT COMPLETELY SEAL THE PERFORATION. A SECOND GRAFTMASTER, 3.0 X 12 MM WAS DEPLOYED AT 16 ATMOSPHERES, BUT THE PERFORATION STILL WAS NOT COMPLETELY SEALED. A THIRD GRAFTMASTER, 4.0 X 16 MM WAS ALSO IMPLANTED AT 16 ATMOSPHERES, AND SUCCESSFULLY SEALED THE PERFORATION. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITH A GOOD RESULT. 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 501303

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GRAFTMASTER 3.0 X 12 MM