BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION

    MDR report key: 3963499 · Received July 24, 2014

    Report

    Report Number
    MW5037455
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    February 7, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ABBOTT LABS - CRITICAL CARE
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, PT WAS A TRANSFER TO OUR FACILITY FOR STEMI WITH V-FIB ARREST. EMERGENT CATH/PCI REVEALS 100% OCCLUSION OF LEFT DOMINANT, PROX CIRC WITH ANOMALOUS TAKE OFF FROM THE RCA. THE 2.5X38 XIENCE XPEDITION DEPLOYED WITH GOOD RESULTS. PT DID WELL AND WAS DISCHARGED (B)(6) 2014 ON MEDICATIONS INCLUDING ASA AND BRILINTA. ON (B)(6) 2014, PT RETURNED TO OFFICE FOR F/U. HE HAD MISSED THE PREVIOUS NIGHT'S DOSE OF BRILINTA. HE WAS AWAKENED AT 0830 THAT AM WITH CHEST PAIN 4/10. CP 2/10 STILL PRESENT AT TIME OF OFFICE VISIT, NOT COMPLETELY RELIEVED WITH SL NTG. EKG IN OFFICE WITH ST DEPRESSION MORE PROMINENT THAN PREVIOUS TRACING. DIRECT ADMIT FOR URGENT CATH. FILMS REVEAL 100% THROMBOTIC OCCLUSION OF PREVIOUSLY PLACED STENT. COPIOUS AMOUNTS OF THROMBUS, ESPECIALLY AT EACH EDGE OF STENT. THE DISTAL EDGE STENTED WITH 3.5X12 XIENCE XPEDITION, PROXIMAL EDGE 3.0X38 XIENCE XPEDITION EXTENDING TOWARD OSTIUM. A VERY SMALL EDGE DISSECTION PROXIMALLY STENTED WITH 3.0X8 XIENCE XPEDITION. PT DID WELL, AND DISCHARGED ON ASA AND BRILINTA TO CONTINUE INDEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434859 XIENCE XPEDITION XIENCE XPEDITION LL NIQ ABBOTT LABS - CRITICAL CARE 2112048

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention