BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1858592 · Received October 1, 2010

    Report

    Report Number
    2024168-2010-02051
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V RX 3.0 X 23 MM (PARR# 1009541-23/LOT# 0051041) MENTIONED IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). REPORTEDLY, THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). IT SHOULD BE NOTED THAT AMI IS CONTRAINDICATED IN THE IFU. IT CAUTIONS THAT THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH RECENT AMI. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PT, WHO HAD EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION (AMI), UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TO TREAT A CALCIFIED AND DIFFUSE LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS 30MM IN LENGTH WITH A TIMI FLOW OF ZERO. AFTER PRE-DILATATION, A 3.0 X 23 MM XIENCE V STENT WAS DEPLOYED IN THE DISTAL HALF OF THE LESION AND A 3.0 X 15MM XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL HALF OF THE LESION, OVERLAPPING THE FIRST STENT. POST-DILATION AND INTRA-VASCULAR ULTRASOUND (IVUS) WERE PERFORMED TO COMPLETE THE PROCEDURE WITH GOOD (TIMI III) RESULTS. ON (B)(6) 2010, THE PT EXPERIENCED A CHEST PAIN IN THE MORNING. ANGIOGRAPHY WAS PERFORMED AND IN-STENT THROMBOSIS WAS OBSERVED. AN ASPIRATION CATHETER WAS USED AND BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFO WAS PROVIDED.

    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 0022341

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IVUS CATHETER| XIENCE V RX 3.0X23MM (PARR#1009541/23/LOT#0051041)