BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1040174 · Received May 8, 2008

    Report

    Report Number
    9616695-2008-00068
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 14, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE, SYMPTOMS/AE: HYPOTENSION, STROKE, TIME OF AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT POST AN UNEVENTFUL RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AN BRADYCARDIC. THE HYPOTENSION WAS TREATED WITH A NEOSYNEPHRINE DRIP. THE BRADYCARDIA WAS NOT TREATED. ADDITIONALLY, POST PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH LEFT ARM AND LEG WEAKNESS, APHASIA AND FACIAL DROOP WHICH WAS INDICATIVE OF A RIGHT MIDDLE CEREBRAL ARTERY INFARCT. A HEAD CT WAS DONE, BUT WAS NEGATIVE. THE PATIENT WAS GIVEN A HEPARIN BOLUS AND WAS STARTED ON A MAINTENANCE DOSE OF HEPARIN. ONE DAY POST PROCEDURE, THE CT WAS REPEATED, BUT REMAINED NEGATIVE. TWO DAYS POST PROCEDURE, AN MRI WAS DONE SHOWING A SHOWER OF SMALL EMBOLIC INFARCTIONS IN THE RIGHT MIDDLE CEREBRAL ARTERY TERRITORY. THREE DAYS POST PROCEDURE, THE PATIENTS STATUS WAS REPORTED AS IMPROVING. SIX DAYS POST PROCEDURE, THE HYPOTENSION WAS RESOLVED. THE PATIENT WAS DISCHARGED TO HOME WITH ORDERS TO HAVE PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY DAILY. NO RESOLUTION DATE WAS PROVIDED FOR THE BRADYCARDIA. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 418850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S ANGIOSEAL| EMBOSHIELD| 5F PIGTAIL| 5X20 BALLOON| 4X30 BALLOON| HEPARIN| 6F SHUTTLE SHEATH| 5F SHEATH| 5F BTK CATHETER