BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1861111 · Received October 4, 2010

    Report

    Report Number
    3004742046-2010-00458
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    2024168-09/10/10-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE RECEIVED, INVESTIGATION IS NOT COMPLETE. THE Z NUMBER HAS NOT YET BEEN RECEIVED. THE INTERNAL RECALL NUMBER IS 2024168-09/10/10-002-R.

    Description of Event or Problem · 1

    ON SEPTEMBER 10, 2010, ABBOTT VASCULAR VOLUNTARILY RECALLED THREE LOTS OF THE RX ACCULINK CAROTID STENT SYSTEM IN THE UNITED STATES FOR A POTENTIAL CATHETER TENSILE STRENGTH ISSUE DISCOVERED INTERNALLY. FOUR (4) OF THE AFFECTED DEVICES HAVE BEEN USED; HOWEVER, THERE WAS NO REPORT OF ANY DELIVERY ISSUES. THERE WERE NO REPORTED ADVERSE PT EFFECTS AS A RESULT OF THIS ISSUE. THIS ACTION DOES NOT AFFECT PTS HAVING SUCCESSFULLY IMPLANTED STENTS. HOWEVER, IF AN AFFECTED DEVICE IS USED IT MAY RESULT IN ACUTE STENT DEPLOYMENT DIFFICULTIES AND SUBSEQUENT INTERVENTION. THIS ACTION DOES NOT AFFECT ANY INVENTORY BEYOND THE UNITS IDENTIFIED HERE. RECALLED PRODUCT: PART # 1011342-20/LOT # 0072061; PART # 1011344-40/LOT # 0070961. AS OF SEPTEMBER 24, 2010, RECONCILIATION OF THE RECALLED DEVICES HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0071361

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 1011342-20/0072061, 1011344-40/0070961