BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2171703 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05073
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). TIP DETACHMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE 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 STENT DELIVERY SYSTEM MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE, BUT WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE IS ALSO NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT. 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, THE PROTECTIVE SHEATH WAS REMOVED AND THE TIP WAS FOUND DETACHED. NO PATIENT INVOLVEMENT. 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 1031541

    Patients

    Seq Age Sex Outcome Treatment
    1