BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3953964 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04733
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL MARGINAL ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. THE 2.5 X 23 MM XIENCE XPEDITION STENT FAILED TO CROSS THE LESION. DURING THE CROSSING ATTEMPT, THE DISTAL SHAFT SEPARATED. THE SEPARATED PART OF THE DEVICE WAS RETRIEVED USING A SNARE. A 2.5 X 15 MM XIENCE XPEDITION STENT WAS ADVANCED NEXT. HOWEVER IT ALSO FAILED TO CROSS THE LESION AND WAS RETRACTED FROM THE ANATOMY. A 2.5 X 16 MM NON-ABBOTT STENT WAS ABLE TO CROSS AND WAS IMPLANTED. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432132 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4032541

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention