BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112585 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03053
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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). CORRECTION: THE DEVICE WAS INITIALLY REPORTED AS RETURNING, BUT HAS NOW BEEN REPORTED AS NOT RETURNING BECAUSE IT WAS DISCARDED AT THE ACCOUNT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT IDENTIFICATION NUMBERS WERE NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UN-PACKAGING OF THE 3.0 X 33 MM XIENCE XPEDITION STENT DELIVERY SYSTEM, RESISTANCE WAS NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH AND THE INNER MEMBER OF THE SHAFT SEPARATED. THE DEVICE WAS NOT USED AND A NEW XIENCE XPEDITION SDS WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212589 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1