BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1828795 · Received September 2, 2010

    Report

    Report Number
    3004742046-2010-00397
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE ACCULINK (1011342-20, (B)(4)) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PROLAPSE, DIFFICULT TO REMOVE FILTER. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT (AE): INTERVENTION REQUIRED TO REPOSITION FILTER. IT WAS REPORTED THAT DURING DEPLOYMENT OF AN RX ACCULINK STENT IN THE LEFT INTERNAL CAROTID ARTERY (LICA) TO LEFT COMMON CAROTID ARTERY (LCCA) TARGET LESION THE SDS JUMPED DISTALLY AND THE STENT WAS IMPLANTED IN THE LICA. A PORTION OF THE PROXIMAL LESION WAS LEFT UNCOVERED. AT THE TIME, THE OPEN RX ACCUNET FILTER WAS INADVERTENTLY PULLED DOWN DISTAL TO THE STENT. THE FILTER WAS PUSHED BACK INTO POSITION USING A VIATRAC BALLOON. A SECOND RX ACCULINK STENT WAS DEPLOYED, OVERLAPPING THE 1ST STENT, TO COVER THE PROXIMAL TARGET LESION. DURING FILTER REMOVAL, THE RETRIEVAL CATHETER (RC) DID NOT COMPLETELY ENCAPSULATE THE FILTER AND THE FILTER INADVERTENTLY MOVED UP TO THE PETROUS AREA. UNSUCCESSFUL ATTEMPTS WERE MADE TO PULL THE FILTER INTO THE RC BY PULLING THE WIRE DOWN INTO THE RC AND BY PULLING THE OPEN FILTER DOWN JUST DISTAL TO THE STENT. THE FILTER WAS ULTIMATELY REMOVED BY PULLING THE OPEN FILTER THROUGH THE STENTS AND INTRODUCER SHEATH. AFTER REMOVAL FROM THE BODY INSPECTION REVEALED NO VISIBLE DAMAGE. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9100951

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention STENT: ACCULINK (1011342-20, (B)(4))| DIL CATH: VIATRAC 7X2 (X2)