BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 698097 · Received April 5, 2006

    Report

    Report Number
    9616695-2006-00029
    Event Type
    Injury
    Date Received
    April 5, 2006
    Date of Event
    December 6, 2005
    Manufacturer
    ABBOTT VASCULAR DEVICES IRELAND, LTD.
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 95% CALCIFIED STENOSIS, 30MM IN LENGTH WAS IDENTIFIED AS THE TARGET LESION IN THE LEFT PROXIMAL CORONARY ARTERY. A 5.0MM EMOSHEILD WAS DEPLYOYED WITHOUT PRE-DILATATION, FOLLOWED BY PRE-STENT DILATION WITH 4.0X30MM BALLOON. DEPLOYMENT OF ONE TAPERED 10-8X40MM FOLLOWED BY POST -DILATION WITH A 5.0X20MM BALLOON RESULTED IN A 10% RESIDUAL STENOSIS. THE PROCEDURE WAS COMPLICATED BY A BRIEF PERIOD OF ASYSTOLE THAT RESOLVED WITHOUT INCIDENT. POST-PORCEDURALLY THE PATIENT COMPLAINED OF GENERALIZED WEAKNESS, BUT THE MODIFIED RANKIN AND NIH SCORES REMAINED UNCHANGED AND NO RELEVANT NEUROLOGICAL SYMPTOMS WERE IDENTIFIED. THE PATIENT WAS DISCHARGED HOME ON THE FOLLOWING DAY ON ASA AND CLOPIDOGREL. IT WAS REPORTED THAT "SHORTLY AFTER DISCHARGE, THE PATIENT NOTED ALTITUDINAL VISUAL LOSS OVER THE SUPERIOR HEMIFIELD OF THE O.S. OPTHALMOLOGY CONSULTATION OBTAINED IN 12/12/20005 REVEALED NO ARTERIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY IN THE OS MOST LIKELY RESULTING FROM AN EMBOLIC EVENT. A NEUROLOGICAL CONSULTATION OBTAINED IN 12/2005 REVEALED PERSISTING SYMPTOMS WITHOUT RESOLUTION AND UNCHANGED MODIFIED RANKING AND NIH SCORES. THE INVESTIGATOR EVALUATED THE PATIENT AGAIN ON 01/2006 AND FOUND THE PATEINT'S SYPTOMS UNCHANGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM ABBOTT VASCULAR DEVICES IRELAND, LTD. XACT 10TX40X136 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other