BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3142869 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03451
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNPACKING A 3.0X23 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS), BUT PRIOR TO PREPPING THE DEVICE, WHEN REMOVING THE PROTECTIVE BALLOON SHEATH WITHOUT RESISTANCE FELT AND WITH NO FORCE APPLIED, THE STENT PULLED OFF OF THE BALLOON, AND THE STENT WAS FOUND STICKING HALFWAY OUT OF THE PROTECTIVE BALLOON SHEATH. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER RX XIENCE XPEDITION SDS WAS UNPACKAGED WITHOUT ISSUE AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243516 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111441

    Patients

    Seq Age Sex Outcome Treatment
    1