BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2060269 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02673
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE STENT IMPLANT, BALLOON, AND SHAFT. THIS SUGGESTS THE SDS HAD BEEN ADVANCED INSIDE THE BODY, WHICH IS INCONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS NOT USED IN THE PATIENT. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. ADDITIONALLY, THERE WERE THREE BENDS IN THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURE OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. IT WAS CONFIRMED THAT THE HYPOTUBE AND JACKET WERE SEPARATED DISTAL TO THE STRAIN RELIEF TUBING. THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED. THE HYPOTUBE JACKET WAS STRETCHED 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 CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. THE SHAFT MOST LIKELY KINKED DURING HANDLING OF THE SDS AND FURTHER MANIPULATION OF THE SHAFT WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE HYPOTUBE SEPARATION AND SUBSEQUENT BENDS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, THE SHAFT SEPARATED. IT WAS NOTED PRIOR TO INSERTION AND THE DEVICE WAS NOT USED ON THE PATIENT. 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 0110241

    Patients

    Seq Age Sex Outcome Treatment
    1