BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1651351 · Received April 2, 2010

    Report

    Report Number
    3004742046-2010-00131
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE EMBOSHIELD NAV6/EMBOLIC PROTECTION SYSTEM, PART #22438-19, LOT #9071751, INDICATED IN THE EVENT DESCRIPTION IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. SYMPTOMS/AE: BRADYCARDIA, HYPOTENSION. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT DURING THE PROCEDURE, TWO LESIONS WERE STENTED, ONE IN THE LCCA OSTIUM AND THE SECOND AT THE LICA BIFURCATION. A FLOW RESTRICTION OCCURRED AND THE PT EXPERIENCED BRADYCARDIA, HYPOTENSION, AND A TRANSIENT ISCHEMIC ATTACK WITH RIGHT UPPER EXTREMITY WEAKNESS AND SLURRED SPEECH. AS THE INTRODUCER SHEATH WAS BELIEVED PRE-OCCLUSIVE, IT WAS WITHDRAWN IN THE ARCH AND THERE WAS SOME IMPROVEMENT IN THE PT'S NEUROLOGICAL STATUS. THE FILTER APPEARED TO ALLOW FLOW THROUGH IT AND BOTH STENTS WERE PATENT WITH NO EVIDENCE OF THROMBUS. AFTER FILTER REMOVAL, FLOW REMAINED SOMEWHAT SLOW AND TISSUE PLASMINOGEN WAS ADMINISTERED. NEUROLOGIC DEFICITS RESOLVED. ANGIOGRAPHY SHOWED NO RESIDUAL STENOSIS IN BOTH STENTS. THE SHEATH WAS REMOVED AND THE PROCEDURE WAS COMPLETED. AFTER THE FILTER REMOVAL, DEBRIS WAS OBSERVED ON THE INSIDE AND OUTSIDE OF THE FILTER. ACT WAS NOT MONITORED DURING THE PROCEDURE. POST-PROCEDURAL CT SCAN OF THE HEAD SHOWED NO ACUTE CHANGE. HYPOTENSION WAS TREATED WITH VASOPRESSORS AND RESOLVED 3 DAYS LATER. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9110951

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DILATATION CATH: VIATRAC 14 PLUS X 2| SHEATH: 6 F DESTINATION SHEATH| STENT: XACT 82098-01, 9091851| WARFARIN