BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1063223 · Received June 17, 2008

    Report

    Report Number
    3004742046-2008-00143
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE EMBOLIC PROTECTION DEVICE WAS DISCARDED. THERE WAS NO DEVICE MALFUNCTION REPORTED. STROKE IS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THIS TYPE OF PROCEDURE AS LISTED IN THE DEVICE INSTRUCTION FOR USE. THE LOT NUMBER WAS PROVIDED. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS / AE: STROKE. TIME OF AE: AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT AT THE END OF A LEFT INTERNAL / COMMON CAROTID ARTERY STENTING PROCEDURE, DURING THE RETRIEVAL OF THE EMBOLIC PROTECTION DEVICE, THE PATIENT BEGAN TO EXPERIENCE A STROKE. SYMPTOMS INCLUDED LEFT LEG DRIFT AND SOME APHASIA AND SLURRING OF WORDS. THE PT WAS TREATED WITH ADDITIONAL HEPARIN, AND NITROGLYCERIN FOR HYPERTENSION RESULTING IN HYPOTENSION. NEOSYNEPHRINE WAS GIVEN FOR THE HYPOTENSION. A STAT HEAD CT SHOWED ISCHEMIA IN THE LEFT PARIETAL CORTEX. AN MRI WAS ALSO DONE AND SHOWED SHOWER-TYPE EMBOLI IN THE LEFT PARIETAL CORTEX. REHABILITATION WAS STARTED IN THE HOSP. TWO DAYS POST PROCEDURE, THE PATIENT'S SPEECH WAS CLEAR. THREE DAYS POST PROCEDURE, THE PATIENT'S CONDITION IMPROVED AND WAS DISCHARGED TO HOME WITH OUTPATIENT PHYSICAL AND SPEECH THERAPIES. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7083151

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S RX ACCULINK X 3| HEPARIN