BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2063499 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02749
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING A STENT CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, LESION CHARACTERISTICS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, AND/OR LESION SIZE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EXPLANTED STENTS INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE GUIDE WIRE WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, THE GUIDE WIRE CAUGHT UNDERNEATH THE IMPLANTED STENT, DAMAGE TO THE STENT, OR INTERACTION WITH OTHER DEVICES. IT IS POSSIBLE THAT ONE OF THE ADDITIONAL DEVICES USED FOR TREATMENT BECAME ENTANGLED WITH THE UNDEREXPANDED GRAFTMASTER STENT AND UPON WITHDRAWAL, THE GRAFTMASTER AND PROMUS STENTS WERE EXPLANTED AND MOVED INTO THE PROXIMAL RIGHT CORONARY ARTERY; HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED AND MAY HAVE ASSISTED IN THE INVESTIGATION. REPORTEDLY THE GRAFTMASTER STENT WAS USED TO TREAT AN ANEURYSM. 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. IN THIS INSTANCE, THE IFU DEVIATION DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD REVEALED NO NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR DAMAGE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE RX PROMUS IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN EMERGENCY CASE AT 3:00 A.M. THE GRAFTMASTER DEVICE WAS SELECTED FOR USE TO TREAT AN ANEURYSM IN THE MID RIGHT CORONARY ARTERY (RCA) IN ORDER TO PROTECT THE ANEURSYM DURING TREATMENT OF THE DISTAL RCA. UPON IMAGE REVIEW (POOR QUALITY) THE GRAFTMASTER STENT IN THE MID RCA LOOKED FULLY DEPLOYED. A PROMUS STENT WAS THEN IMPLANTED OVERLAPPING THE EDGE OF THE GRAFTMASTER STENT AND THE DISTAL RCA WAS SUCCESSFULLY TREATED. UPON REVIEW OF THE CASE THE NEXT DAY, ON DIFFERENT IMAGING EQUIPMENT, THE PHYSICIAN REALIZED THAT THE GRAFTMASTER AND THE PROMUS STENT WERE NO LONGER DEPLOYED IN THE MID RCA AND WERE NOW LOCATED IN THE PROXIMAL RCA. IT IS BELIEVED THAT DUE TO THE POOR IMAGE ON THE OLDER EQUIPMENT USED DURING THE PROCEDURE THAT THE GRAFTMASTER STENT WAS UNDEREXPANDED AND THAT THE TREATMENT WITH ADDITIONAL PROMUS BALLOONS AND STENT DELIVERY SYSTEMS GOING IN AND OUT TO TREAT THE DISTAL RCA, PULLED THE UNDEREXPANDED GRAFTMASTER AND THE PROMUS STENT BACK INTO THE PROXIMAL RCA. THE PATIENT WAS STABLE AND WAS TRANSFERED AT THIS TIME FROM KAISER REDWOOD CITY TO KAISER SAN FRANCISCO, WHERE THE MIGRATED GRAFTMASTER WAS DEPLOYED IN THE PROXIMAL RCA (UNINTENDED SITE), AND THE PROMUS STENT WAS SNARED FROM THE ANATOMY. A SECOND GRAFTMASTER WAS SELECTED TO TREAT THE ANEURYSM; HOWEVER, FAILED TO CROSS AND AS ATTEMPTS TO CROSS WITH ADDITIONAL BALLOONS FOR DILATATION ALSO FAILED, THE GRAFTMASTER WAS NOT REINTRODUCED INTO THE ARTERY. 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 630530

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R STENT: RX PROMUS