BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4221896 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07183
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. ARTERIAL PERFORATION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE WHICH PROGRESSED TO AN INTERVENTIONAL PROCEDURE OF THE MILDLY CALCIFIED, DE NOVO, LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 4.0 X 12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT CROSS THE LESION AND WAS REMOVED WITHOUT ISSUE. IT WAS NOTED THAT DIRECT STENTING WITH THE 3.5 X 28 MM XIENCE XPEDITION STENT AT 12 ATMOSPHERE (ATM) WAS COMPLETED FOR DEPLOYMENT. A SECOND STENT INFLATION ATTEMPT AT UNSPECIFIED ATM RESULTED IN A VESSEL PERFORATION AND THE PATIENT BECAME UNRESPONSIVE. IT WAS NOTED THAT GUIDE WIRE POSITION WAS LOST IN THE VESSEL. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED AND THE PATIENT WAS TRANSFERRED TO SURGERY FOR BYPASS. POST SURGERY THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701187 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4061942

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S