BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3171247 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03761
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. 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. 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 DURING A MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, THE 2.5X15 XIENCE XPEDITION FAILED TO CROSS THE MODERATELY CALCIFIED LESION. A 2.5X12MM XIENCE XPEDITION WAS SUCCESSFULLY IMPLANTED. A 2.5X08MM XIENCE XPEDITION FAILED TO CROSS THE LESION AND DURING REMOVAL DISLODGED AT THE OSTIUM OF THE RCA. REPORTEDLY, NO RESISTANCE WAS FELT DURING REMOVAL. A NON-ABBOTT GUIDE WIRE WAS PLACED AND A NON-ABBOTT BALLOON WAS ADVANCED OVER THE WIRE, THROUGH THE DISLODGED STENT AND INFLATED TO 3 ATMOSPHERES. THE DISLODGED STENT, WIRES AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272166 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012241

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention