BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1788703 · Received August 5, 2010

    Report

    Report Number
    2024168-2010-01609
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LESION; THEREFORE, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: SAFETY AND EFFECTIVENESS OF THE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH CHRONIC TOTAL OCCLUSIONS. THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, PART # 1009541-28, LOT # 0021141, SERIAL # UNK INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: SUB ACUTE STENT THROMBOSIS REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: TWO DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT TWO XIENCE STENTS WERE IMPLANTED SIDE BY SIDE, OVERLAPPING AT THE LESION ON (B)(6) 2010. ON (B)(6) 2010, THE PT RETURNED TO PERCUTANEOUS CORONARY INTERVENTION OF A NEW LESION IN THE LEFT ANTERIOR DESCENDING. DURING ANGIOGRAPHY, THERE WAS THROMBOSIS CONFIRMED IN THE STENTS PREVIOUSLY DEPLOYED ON (B)(6) 2010 AND THE VESSEL WAS TOTALLY OCCLUDED. THE PREVIOUSLY DEPLOYED STENTS WERE TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY TO TREAT THE SUB ACUTE STENT THROMBOSIS. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0030942

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention PART # 1009541-28, LOT # 0021141, SERIAL # UNK| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM