BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1870597 · Received October 12, 2010

    Report

    Report Number
    2953144-2010-02458
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE RX ACCULINK (1001344-30, (B)(4)) AND EMBOSHIELD NAV 6 (22438-19, (B)(4)) ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ACHIEVED HEMOSTASIS OF THE RIGHT FEMORAL ARTERY AFTER RIGHT INTERNAL CAROTID STENTING IMPLANTATION. TWO MINUTES LATER, OOZING OCCURRED, TREATED WITH DIGITAL PRESSURE AND APPLICATION OF A PRESSURE DRESSING. OOZING RESOLVED IN CATH LAB. THERE WAS NO BLEEDING OR HEMATOMA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED VIA TRIAL THAT AFTER RX ACCULINK STENT POST-DILATATION IN THE RIGHT INTERNAL CAROTID ARTERY, NO FLOW OCCURRED. NITROGLYCERIN WAS GIVEN AND THE EMBOSHIELD NAV 6 FILTER BASKET WAS RETRIEVED; VIGOROUS FLOW WAS RESTORED. POST PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH BLURRED AND DOUBLE VISION. MRI SHOWED NUMEROUS TINY ACUTE LACUNAR INFARCTS, THE MAJORITY OF WHICH WERE ON THE RIGHT. PLAVIX AND COUMADIN WERE STARTED AND HOSPITALIZATION WAS PROLONGED. IN THE PHYSICIAN'S OPINION, THE BILATERAL CEREBRAL INFARCTS WERE RELATED TO A HISTORY OF CHRONIC ATRIAL FIBRILLATION. POST PROCEDURE, ASYMPTOMATIC BRADYCARDIA AND HYPOTENSION OCCURRED THAT PERSISTED MORE THAN 48 HOURS AND WAS TREATED WITH NEO-SYNEPHRINE FOR ABOUT 2 DAYS, FOLLOWED BY PSEUDOEPHEDRINE. ON (B)(6)2010, AT TIME OF DISCHARGE, ANTI-HYPERTENSIVE MEDICATIONS WERE HELD. HYPOTENSION AND BRADYCARDIA HAD RESOLVED. AT A FOLLOW-UP VISIT ON (B)(6)2010, THE MINOR DIPLOPIA WAS IMPROVING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention RX ACCULINK (1001344-30, 8112551)| VIATRAC 5.5 X 20 X 135| HEPARIN| EMBOSHIELD NAV 6 (22438-19, LOT# 0042651)