BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET CAROTID EMBOLIC PROTECTION SYSTEM

    MDR report key: 742154 · Received July 27, 2006

    Report

    Report Number
    3004742046-2006-00324
    Event Type
    Injury
    Date Received
    July 27, 2006
    Date of Event
    June 30, 2006
    Report Date
    July 3, 2006
    Manufacturer
    GUIDANT VASCULAR SOLUTIONS
    Product Code
    NFA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK, PART # 1011342-30, LOT # 6061251, REFERENCED IN B5 AND D11, IS BEING FILED UNDER MFR REPORT # 3004742046-2006-00321.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS: BLURRED VISION AND INABILITY TO FOCUS. TIME OF SYMPTOMS: DURING THE PROCEDURE ON 6/30/06. IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR THE RCC, THE PT EXPERIENCED A STROKE RESULTING IN LEFT HOMONYMOUS HEMIANOPIA. ACCORDING TO THE NEUROLOGY CONSULT, THIS WAS LIKELY DUE TO A SMALL ERYTHEMATOUS PLAQUE WHICH LODGED IN ONE OF THE BRANCHES OF THE MCA BECAUSE THE STENOSIS AND THE STENT WAS DONE ON THE RIGHT INTERNAL CAROTID ARTERY AND THAT COULD AFFECT A SMALL PART OF THE VISUAL TRACT. THE CAROTID ANGIOGRAM REVEALED A VERY HIGH GRADE AND IRREGULAR/ULCERATED STENOSIS IN THE DISTAL RIGHT COMMON CAROTID ARTERY, PROXIMAL TO THE REGION OF THE BULB. THE RIGHT EXTERNAL CAROTID ARTERY WAS ALMOST TOTALLY OCCLUDED AND THE RIGHT INTERNAL CAROTID ARTERY WAS PATENT WITH 50% STENOSIS, PROXIMALLY. THE STENTING WAS DESCRIBED AS SUCCESSFUL, BUT THE PT EXPERIENCED BLURRED VISION AND INABILITY TO FOCUS DURING THE PROCEDURE AND COMPLAINED OF PAIN IN THEIR RIGHT EYE. CT AND MRI SCANS WERE PERFORMED AND THE MRI SCAN FOUND AN ACUTE ISCHEMIC INFARCT. ACUTE ISCHEMIC INFARCT WAS CONFIRMED WITH ADC MAP INVOLVING THE RIGHT PCA DISTRIBUTION INVOLVING THE RIGHT MESIOTEMPORAL LOBE, RIGHT POTEROTEMPORAL OCCIPITAL GYRUS, CALCARINE GYRUS AND MESIO OCCIPITAL LOBE AS WELL AS THE RIGHT PULVINAR AND DORSAL LATERAL RIGHT THALAMUS. NO ACUTE INTRACRANIAL ABNORMALITY ON UN-ENHANCED CT. THE PT WAS GIVEN MEDS AND THE EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE CONDITION IS REPORTED TO BE IMPROVED AND CONTINUING. NO ADDITIONAL INFO WAS AVAILABLE. THE RX ACCULINK, PART #1011342-30, LOT#6061251, REFERENCED IN B5 AND D11, IS BEING FILED UNDER MFR REPORT # 3004742046-2006-00321. CAPTURE STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET CAROTID EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NFA GUIDANT VASCULAR SOLUTIONS NA 6052451

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S PIGTAIL CATHER RX ACCULINK| GLIDEWIRE 6F SHUTTLE SHEATH| MAGIC TORQUE WIRE| SIMMONS II CATHETER 7X2 BALLOON