BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1329221 · Received February 25, 2009

    Report

    Report Number
    2024168-2009-00299
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    January 29, 2009
    Report Date
    February 3, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN THIS CASE, IT IS POSSIBLE THAT THE ECG CHANGES AND THE ANGINA ARE SECONDARY EFFECTS OF THE THROMBOSIS WHICH REQUIRED PTCI. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: ANGINA AND THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2009, A XIENCE V STENT WAS IMPLANTED IN THE PROXIMAL RCA. THE PT WAS A MALE WITH HISTORY OF HYPERLIPIDEMIA, HYPERTENSION, AND UNSTABLE ANGINA. THE PT RECEIVED A LOADING DOSE OF CLOPIDOGREL AND ASA PRIOR TO THE PROCEDURE. AFTER THE INDEX PROCEDURE, THE PT DEVELOPED CHEST PAIN AND ECG ELEVATIONS IN THE INFERIOR LEADS WHILE IN THE HOLDING AREA. THE PATIENT UNDERWENT AN EMERGENT REPEAT CATHETERIZATION AND WAS NOTED TO HAVE DIFFUSE THROMBUS OR MARKED TISSUE PROLAPSE WITHIN THE PREVIOUSLY PLACED PROXIMAL RCA STENTS. ANOTHER XIENCE V STENT WAS PLACED, THE PT WAS GIVEN UNK MEDICATIONS AND A FETCH CATHETER WAS USED. THE EVENT WAS CONSIDERED RESOLVED. THE PT WAS DISCHARGED FROM THE HOSPITAL ABOUT TWO DAYS LATER, ON CLOPIDOGREL AND ASA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention DILATATION CATHETER: MAVERICK 2.5 X 15 MM| POWERSAIL 3.75 X 15 MM| GUIDE WIRE: COUAGAR XT| GUIDE CATHETER: 6FR JR4