BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1505629 · Received October 12, 2009

    Report

    Report Number
    3004742046-2009-00269
    Event Type
    Injury
    Date Received
    October 12, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 22, 2009
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR. THE RX ACCULINK INSTRUCTIONS FOR USE LISTS STROKE AS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO PRODUCT QUALITY DISCREPANCIES WERE REPORTED DURING THE INSPECTION PRIOR TO USE. A CONCLUSIVE CAUSE FOR THE REPORTED STROKE COULD NOT BE IDENTIFIED. INFORMATION AVAILABLE IN THE CASE DESCRIPTION WAS NOT SUFFICIENT TO DETERMINE RELATION BETWEEN THE STROKE AND THE ABBOTT VASCULAR DEVICE QUALITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES, WHICH COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    SYMPTOMS/AE: STROKE. TIME OF SYMPTOMS: ONE DAY POST PROCEDURE. DEVICE MALFUNCTION: NONE. IT WAS REPORTED THAT ONE DAY POST A SUCCESSFUL PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY WITH THE RX ACCULINK STENT, THE PATIENT EXPERIENCED TEMPORARY LOSS OF PERIPHERAL VISION IN THE LEFT EYE. THE CT WAS NEGATIVE AND NO TREATMENT WAS GIVEN. THE PATIENT WAS DIAGNOSED WITH THE CEREBRAL INFARCT OF THE RIGHT OCCIPITAL. THE VISION LOSS WAS RESOLVED THE NEXT DAY AND THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 9051851

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| S RX ACCUNET EMBOLIC PROTECTION SYSTEM| (PART #1011649-75, LOT #9030351)