BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001895 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01226
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT REVEALED BLOOD ON THE DISTAL SHAFT AND IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH A GUIDE WIRE HAVING BEEN LOADED INTO THE LUMEN SUGGESTING HANDLING AND /OR POSSIBLE USE IN THE BODY. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE TWO KINKS IN THE HYPOTUBE THAT WERE NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. IT WAS CONFIRMED THAT THE HYPOTUBE AND JACKET WERE SEPARATED. THE FRACTURE FACES WERE OVALED AND THE JACKET WAS STRETCHED AND JAGGED AT THE SEPARATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THAT KINKS AND SHAFT SEPARATIONS ARE NOT THE RESULT OF THE MANUFACTURING PROCESS, ALL SDS ARE VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS, INCLUDING A FINAL INSPECTION OF THE PRODUCT BEFORE BEING INSERTED INTO THE DISPENSER COIL. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IN THIS INSTANCE, THE SHAFT MOST LIKELY KINKED DURING HANDLING AND FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE REPORTED SHAFT SEPARATION AND SUBSEQUENT KINKS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS FOUND TO BE BROKEN [DAMAGED] PRIOR TO USE; THEREFORE, THE DEVICE WAS NOT USED ON THE PATIENT. SUBSEQUENT TO THE INITIAL REPORTED INFORMATION, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS THE SHAFT OF THE XIENCE V DELIVERY SYSTEM THAT WAS BROKEN. RETURNED DEVICE ANALYSIS CONFIRMED THE SHAFT WAS SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0090941

    Patients

    Seq Age Sex Outcome Treatment
    1