BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2133802 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04339
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. TIP DETACHMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING (PROCESSING AND/OR HANDLING), HANDLING DURING REMOVAL FROM PACKAGING AT THE ACCOUNT, PREPARATION/USE OF THE CATHETER, OR INTERACTION WITH LESION/ANATOMY OR ACCESSORY DEVICES. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR TIP TENSILE FORCE. RETURN OF THE XIENCE V SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE AS WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR TIP DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY TIP PULL FORCE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR TIP DETACHMENTS FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE XIENCE V RX DELIVERY SYSTEM, THE TIP OF THE CATHETER SEPARATED. NO FORCE WAS APPLIED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE V RX WAS USED SUCCESSFULLY. THERE WAS NO SIGNIFICANT CLINICAL DELAY. 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 1032141

    Patients

    Seq Age Sex Outcome Treatment
    1