BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4200550 · Received October 24, 2014

    Report

    Report Number
    2024168-2014-06990
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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. ADDITIONALLY, DISSECTION AND OCCLUSION ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH AN ACUTE TAKEOFF OF THE CIRCUMFLEX (CX) ARTERY THE 2.25 X 23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) AND THE 2.25 X 15 MM XIENCE ALPINE SDS WERE ADVANCED, BUT FAILED TO CROSS THE LESION AND WERE REMOVED FROM THE ANATOMY. A 2.5 X 23 MM XIENCE XPEDITION SDS WAS ADVANCED AND FAILED TO CROSS THE LESION, HOWEVER, A VESSEL DISSECTION WAS NOTED AND THE LAD BECAME OCCLUDED. THE PATIENT EXPERIENCED CARDIAC ARREST AND EMERGENT MEASURES WERE IMPLEMENTED. A CARDIOPULMONARY SUPPORT SYSTEM (CPS) WAS USED AND THE PATIENT WAS DEFIBRILLATED AND CARDIOPULMONARY RESUSCITATION (CPR) BEGUN. ADDITIONALLY, 6 UNSPECIFIED XIENCE STENTS WERE IMPLANTED AND AFTER APPROXIMATELY 15-20 MINUTES THE LAD AND THE LEFT MAIN (LM) WAS OPENED AND RE-FLOW WAS ESTABLISHED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABILIZED, BUT IN CRITICAL CONDITION. DURING THE EVENING THE PATIENT EXPERIENCED EDEMA; THE PATIENT WAS INTUBATED AND AN IMPELLA WAS PLACED. ONE DAY POST PROCEDURE THE PATIENT REMAINED IN CRITICAL CONDITION, BUT IMPROVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678611 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 403124N

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R