BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2033297 · Received March 30, 2011

    Report

    Report Number
    2024168-2011-02154
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    April 2, 2009
    Report Date
    April 2, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    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. DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS) POST-DEPLOYMENT MAY BE RELATED TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON RUPTURES/LEAKS, POOR BALLOON REFOLD, DEFLATION TECHNIQUE, INTERACTION OF THE BALLOON WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO REMOVAL, DAMAGE TO THE STENT, INTERACTION WITH THE PATIENT ANATOMY, OR RESISTANCE WITH THE GUIDE WIRE. IN MANUFACTURING, ALL SDS ARE 100% INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER STENT DEPLOYMENT AND BALLOON DEFLATION. RETURN OF THE GRAFTMASTER SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT WAS REPORTED THE GRAFTMASTER WAS USED TO TREAT AN ANEURYSM IN THE LAD. IT SHOULD BE NOTED THE GRAFTMASTER OTW 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. IT DOES NOT APPEAR THAT THE REPORTED IMPROPER USE TO TREAT AN ANEURYSM WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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 DIFFICULT TO REMOVE POST DEPLOYMENT OR BALLOON REFOLD ISSUES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER WAS USED TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ANEURYSM. IT WAS PLACED SUCCESSFULLY COVERING THE ANEURYSM. POOR BALLOON REFOLD AND RESISTANCE REMOVING THE STENT DELIVERY SYSTEM POST-STENT DEPLOYMENT WERE REPORTED. NO PATIENT EFFECTS 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 433400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR