BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 703455 · Received April 21, 2006

    Report

    Report Number
    3004742046-2006-00174
    Event Type
    Injury
    Date Received
    April 21, 2006
    Date of Event
    March 23, 2006
    Report Date
    March 23, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NFA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED A STENT PROCEDURE IN THE RIC USING THE ACCULINK STENT DELIVERY SYSTEM (THE LESION WAS PRIMARILY LOCATED IN THE CAROTID BULB PER ACCOUNT MGR); THE PHYSICIAN WAS ABLE TO COVER THE LESION COMPLETELY. IN HIS ATTEMPT TO CAPTURE THE ACCUNET, THE PHYSICIAN MET WITH DIFFICULTY WHEN ADVANCING A 2ND GENERATION RC SECONDARY TO ANGULATION IN THE CAROTID BULB. THE PT'S NECK WAS ROTATED BOTH WAYS IN AN ATTEMPT TO BETTER CAPTURE THE ACCUNET. THE PHYSICIAN MADE A SECOND ATEMPT TO RECOVER THE FILTER BASKET WITH A 2ND GENERATION RC AND WAS UNSUCCESSFUL AS THE CATHETER KEPT HITTING THE PROXIMAL END OF THE SENT. THE PHYSICIAN POST-DILATED WITH A 5-20 BALLOON AND WAS ABLE TO RECAPTURE THE ACCUNET USING A GENERATION 1 RC. THE PT EXPERIENCED SYMPTOMS OF "VESSEL SPASM." TREATMENT: NITROGLYCERINE WAS ADMINISTERED AND THE PT IMPROVED, STABILIZED, RESPONDED TO QUESTIONS, AND WAS ABLE TO FOLLOW COMMANDS. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NFA GUIDANT ENDOVASCULAR SOLUTIONS NA 5093052

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention