BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1772371 · Received July 23, 2010

    Report

    Report Number
    3004742046-2010-00329
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF ANGINA, HYPOTENSION AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS LISTED IN THE ACCULINK INSTRUCTIONS FOR USE (IFU). THE REPORTED TREATMENT WITH MEDICATION AND HOSPITALIZATION APPEAR TO BE SECONDARY EFFECTS OF THE REPORTED PT AFFECTS THAT OCCURRED DURING THIS INCIDENT. 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 OR DESIGN. THE RX ACCULINK (PART 1011342-30, LOT 0012551), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: MYOCARDIAL INFARCTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT AFTER IMPLANTATION OF TWO ACCULINK STENTS IN THE LEFT INTERNAL CAROTID ARTERY, THE PT EXPERIENCED HYPOTENSION AND A MYOCARDIAL INFARCTION (MI). THE PT WAS STARTED ON VASOPRESSORS, BUT WAS DISCONTINUED AFTER LESS THAN 2 HOURS. THE MI WAS TREATED WITH NITROGLYCERIN AND MORPHINE. THE PT WAS MONITORED FOR AN EXTRA DAY AND THE PT TROPONIN LEVELS DECREASED. CLINICAL SYMPTOMS HAVE RESOLVED, BUT IS STILL IN THE HEALING PROCESS POST MI. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0050361

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S STENT: RX ACCULINK (PART 1011342-30, LOT 0012551)| OTHER: BIVALIRUDIN| EMBOLIC PROTECTION: ACCUNET, LOT# 0011152