BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2162752 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04967
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE 3.5 X 16 GRAFTMASTER IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE STENT DELIVERY SYSTEM (SDS) OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY INDICATE THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. IN THIS CASE, NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BOTH OF WHICH MAY HAVE AIDED THE INVESTIGATION. IT IS POSSIBLE THAT THE STENT DID NOT HAVE PROPER VESSEL WALL APPOSITION TO PROPERLY SEAL THE PERFORATION; HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL SDS ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT ONLINE DURING THE MANUFACTURING PROCESS. IT WAS REPORTED THE GRAFTMASTER WAS USED IN THE RENAL ARTERY. IT SHOULD BE NOTED THE GRAFTMASTER INSTRUCTIONS FOR USE 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL (LEAK), THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFORATION WAS LOCATED IN THE PROXIMAL RENAL ARTERY. THE PERFORATION WAS CAUSED BY A NON-ABBOTT DEVICE. A 3.5 X 16 MM GRAFTMASTER AND A 4.0 X 16 MM GRAFTMASTER WERE IMPLANTED. ALTHOUGH THE BLOOD FLOW FROM THE PERFORATION DECREASED, IT WAS NOT COMPLETELY SEALED BY THE STENTS. NO FURTHER TREAMENT WAS PERFORMED. NO ADVERSE PATIENT SEQUELAE WERE REPORTED. 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 622814

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR