BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2951097 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00757
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. THE SHAFT WAS SEPARATED. THE REPORTED LEAK COULD NOT BE TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE; HOWEVER, IT IS LIKELY THAT THE REPORTED LEAK OCCURRED DUE TO THE CONFIRMED SHAFT LUMEN COMPROMISE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, 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 THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT THROUGH THE 5 FRENCH GUIDE CATHETER TO THE PREDILATED, HEAVILY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION IN THE OSTIAL LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT. DURING INFLATION OF THE XIENCE XPEDITION TO AN UNKNOWN PRESSURE, THE PHYSICIAN FELT THE SHAFT CRACK, BUT THE SHAFT REMAINED IN ONE PIECE. THE PRESSURE ON THE SDS DECREASED AND THE XIENCE XPEDITION STENT FLOATED OFF OF THE SDS INTO THE PROFUNDA AND THEN TO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DISLODGED STENT WAS CRUSHED AGAINST THE SFA WALL WITH A PERIPHERAL STENT. A 2.75X23 XIENCE XPEDITION WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION WITHOUT FURTHER INCIDENT. THIS WAS CONSIDERED TO HAVE CAUSED A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WERE NO CHANGES TO THE ELECTROCARDIOGRAM DURING THE DEVICE ISSUE. THE PATIENT REMAINED STABLE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54995 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2090541

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention