BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1685829 · Received May 11, 2010

    Report

    Report Number
    3004742046-2010-00196
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 16, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE RX ACCUNET (PART 1011649-65, LOT 9080651), AND THE RX ACCULINK (PART 1011341-30, LOT 9050151), ARE BEING FILED UNDER SEPARATE MFR#'S.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULTY REMOVING FILTER, ENTANGLEMENT OF FILTER WITH STENT, STENT DISLODGED FROM POSITION, DETACHED WIRE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: SURGICAL EXPLANATION OF STENTS AND REMOVAL OF DETACHED WIRE. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL/COMMON CAROTID ARTERY STENTING PROCEDURE (TWO STENTS PLACED), AFTER FILTER RECOVERY, RESISTANCE WAS MET WHILE PULLING THE FILTER THROUGH THE STENT LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE FILTER WAS PULLED WITH FORCE, DRAGGING THE STENT FROM THE ICA INTO THE COMMON CAROTID ARTERY AND DETACHING THE FILTER WIRE INTO TWO PIECES. THE PATIENT WAS TAKEN TO SURGERY WHERE THE TWO STENTS AND THE FILTER WIRE WERE REMOVED. TWO NEW RX ACCULINK STENTS WERE PLACED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9031751

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention STENT: RX ACCUNET (PART 1011649-65, LOT 9080651)| RX ACCULINK II (PART 1011343-40, LOT 9031751)