BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001763 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01214
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    November 14, 2010
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE TIP AND BALLOON AND THICK CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH HANDLING AND SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING PREPARATION OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. A NON-ABBOTT STOPCOCK WAS RETURNED ATTACHED TO THE HUB AND WAS IN THE OFF POSITION. IT WAS CONFIRMED THAT THE TIP HAD SEPARATED AT THE DISTAL END OF THE DISTAL SEAL AND WAS NOT RETURNED. THE FRACTURE FACE WAS SLIGHTLY JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). FACTORS THAT CAN CONTRIBUTE TO TIP DETACHMENT INCLUDE BUT ARE NOT LIMITED TO MANUFACTURING, REMOVAL FROM PACKAGING AT THE ACCOUNT, HANDLING DURING PREPARATION/USE, OR INSERTION OF THE GUIDE WIRE. A MANDREL WAS ADVANCED THROUGH THE TIP PAST THE PROXIMAL SEAL AND THIS MET MANUFACTURING CRITERIA. IT IS POSSIBLE THE SDS WAS INADVERTENTLY MISHANDLED DURING PREPARATION, RESULTING IN THE TIP DETACHING; HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO RELATED 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. A DEFINITIVE CAUSE OF THE TIP DETACHMENT COULD NOT BE DETERMINED, HOWEVER, THE BENDS IN THE HYPOTUBE ARE LIKELY RELATED TO OPERATIONAL CONTEXT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR TIP DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY TIP PULL FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, PRIOR TO LOADING ONTO THE GUIDE WIRE, THE SOFT TIP WAS NOTED TO BE DETACHED AND MISSING FROM THE XIENCE V. 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 0052741

    Patients

    Seq Age Sex Outcome Treatment
    1