BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2223758 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05947
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. GUIDE WIRE: GLIDEWIRE; CHOICE ESEX. GUIDE CATH: MINNIE, SIMMONS. SHEATH: 5FR. (B)(4) INDICATION FOR USE AND ABOVE RATED BURST PRESSURE. RETURN OF THE GRAFTMASTER MAY HAVE ASSISTED THE INVESTIGATION. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE GRAFTMASTER WAS INFLATED TO 18 ATMOSPHERES WHICH IS ABOVE THE RATED BURST PRESSURE. IT SHOULD BE NOTED THAT THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU) STATES THAT THE RATED BURST PRESSURE (RBP) FOR A 5.0 MM DIAMETER IS 16 ATM. THEREFORE, IT IS POSSIBLE THAT THE OVER-INFLATION OF THE DEVICE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. IT WAS REPORTED THE GRAFTMASTER WAS USED IN THE FEMORAL ARTERY. IT SHOULD BE NOTED THE GRAFTMASTER 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 FINISHED DEVICE HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE REPORTED BALLOON RUPTURE IS MOST LIKELY RELATED TO OVER-INFLATION OF THE BALLOON AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5.0 X 26 MM GRAFTMASTER STENT WAS SELECTED FOR TREATMENT OF A VESSEL RUPTURE IN THE RIGHT COMMON FEMORAL ARTERY THAT HAD OCCURRED DURING DILATATION OF THE VESSEL. UPON INFLATION OF THE STENT DELIVERY SYSTEM BALLOON TO 18 ATMOSPHERES, THE STENT WAS DEPLOYED; HOWEVER, THE BALLOON RUPTURED. ALTHOUGH THE STENT WAS DEPLOYED SUCCESSFULLY, A NON-ABBOTT DILATATION WAS USED TO DILATE THE GRAFTMASTER STENT TO ENSURE FULL APPOSITION AND THAT THE RUPTURE WAS SEALED SUCCESSFULLY. 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 594452

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR