BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 752888 · Received August 18, 2006

    Report

    Report Number
    3004742046-2006-00358
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    July 19, 2006
    Report Date
    August 1, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO RX ACCULINK PART#1011342-30, LOT #6060251 ARE BEING FILED RESPECTIVELY UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO DEPLOY STENT #1. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: VISUAL CHANGES, CONFUSION. TIME OF SYMPTOMS/AE: POST-PROCEDURE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE RIGHT INTERNAL AND COMMON CAROTID ARTERIES, THE PHYSICIAN HAD DIFFICULTY DEPLOYING STENT #1, "IT APPEARED TO ADVANCE FORWARDS," WHICH RESULTED IN THE NEED TO DEPLOY ANOTHER STENT (#2) TO COVER THE LESION. AFTERWARDS, THERE WAS "STILL A TAPERING PORTION OF THE COMMON CAROTID AND AN ADDITIONAL" STENT (#3) WAS PLACED. THERE WERE NO NEUROLOGIC DEFICITS NOTED AT THE END OF THE PROCEDURE, HOWEVER, ON THE NIGHT OF THE PROCEDURE, IN 2006, THE PATIENT STARTED TO DEVELOP VISUAL CHANGES AND CONFUSION. HE WAS ALSO NOTED TO BE HYPOTENSIVE AND TREATED WITH DOPAMINE AND FLUIDS IN THE HOSPITAL AND WAS TO BE DISCHARGED HOME WITH MEDICATION. THE INITIAL CT HEAD SCAN ON DAY OF EVENT SHOWED NO ACUTE CHANGE, BUT TWO DAYS LATER, THE CT SHOWED AN INFARCTION IN THE ANTERIOR ASPECT OF THE RIGHT FRONTAL LOBE, AND IT HAD A MILDLY HEMORRHAGIC COMPONENT TO IT. THE SAME DAY, THE PATIENT WAS DESCRIBED AS HAVING VERY POOR VISION IN THE RIGHT EYE. THE PATIENT'S VISUAL LOSS WAS THOUGHT TO BE RELATED TO OPTIC NEURITIS SECONDARY TO EMBOLUS TO THE OPHTHALMIC ARTERY POST STENTING, AND IS LIKELY TO BE PERMANENT. THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 5111151

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| S GUIDING CATHETER: V TEK| HEAVY WHITE BUDDY WIRE| GUIDE WIRE: BMW| RX ACCUNET| 5.5 BALLOON| DILATATION CATHETER: 4X40 CROSS SAIL| OTHER: EV3 SPIDER RX| 7X20 AVIATOR| 7F SHUTTLE| SHEATH: 6FX90CM SHUTTLE| STENTS: TWO RX ACCULINK