BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2161425 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04856
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 VISIBLE IN THE TIP, CONSISTENT WITH THE STENT DELIVERY SYSTEM AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN MARKERS WITH NO DAMAGE NOTED. THE TIP WAS SEPARATED AT THE DISTAL END OF THE DISTAL SEAL, CONFIRMING THE REPORTED SEPARATION. THE MATERIAL AT THE SEPARATION WAS JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE INNER DIAMETER OF THE SEPARATION WAS MEASURED AND MET MANUFACTURING CRITERIA. 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. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORD (NCMR) FOR THIS LOT RELATED TO THE REPORTED FAILURE TO ADVANCE OR SUBSEQUENT DAMAGE NOTED. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR TIP DETACHMENTS FOR THIS LOT. IN THIS CASE, IT IS POSSIBLE THE TIP WAS INADVERTENTLY HANDLED DURING PREPARATION OR DURING LOADING OF THE GUIDE WIRE; HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED TIP DETACHMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MID LEFT ANTERIOR DESCENDING ARTERY STENTING PROCEDURE, WHILE ADVANCING OVER THE WIRE, PRIOR TO ENTERING THE ANATOMY, THE TIP OF THE DISTAL END OF THE DELIVERY SYSTEM DETACHED. THERE WAS NO INTERVENTION AND NO INJURY TO THE PATIENT. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 1020241

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR