BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1726133 · Received June 15, 2010

    Report

    Report Number
    3004742046-2010-00255
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 21, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    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). (B) (4). IT IS POSSIBLE THAT THE STENT JUMPED OR INACCURATE PLACEMENT MAY BE A RESULTS OF, BUT NOT LIMITED TO, PT'S VESSEL GEOMETRY OR THE VESSEL DIAMETER WHICH COULD HAVE BEEN LARGER THAN THE STENT OR WHEN THE STENT DOES NOT APPOSE THE VESSEL WALL WHEN THE STENT IS FULLY DEPLOYED, AND WHEN THERE IS INADVERTENT MOVEMENT OF THE HANDLING DURING DEPLOYMENT OR THE POSITIONING OF THE STENT PRIOR TO DEPLOYMENT WAS NOT OPTIMAL. FURTHERMORE, THE ACCULINK INSTRUCTION FOR USE NOTES, UNDER STENT DEPLOYMENT CAUTION, THAT PRIOR TO STENT DEPLOYMENT, REMOVE ALL SLACK FROM THE DELIVERY SYSTEM. BASED ON AVAILABLE INFO AND WITHOUT THE PRODUCT BEING RETURNED FOR ANALYSIS, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. THE RX ACCULINK (PART 1011342-30, LOT 9091051), INDICATED IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT #1 JUMPED. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: REQUIRED PLACEMENT OT AN ADDITIONAL UNPLANNED STENT. IT WAS REPORTED, VIA TRIAL, THAT DURING A LEFT COMMON CAROTID ARTERY STENTING PROCEDURE, THE RX ACCULINK STENT JUMPED DURING DEPLOYMENT AND LANDED DISTAL TO THE LESION. A SECOND RX ACCULINK STENT WAS PLACED, BUT WAS DEPLOYED PROXIMAL TO THE LESION. A THIRD NON-ABBOTT STENT WAS PLACED, SUCCESSFULLY, WITHIN THE LESION, AND OVERLAPPING THE TWO PREVIOUSLY PLACED STENTS; HOWEVER, PLACEMENT OF THE STENT RESULTED IN A SLIGHT TILTING OF THE DISTAL RX ACCULINK STENT. REPORTEDLY, THE STENT HAD THE POTENTIAL TO COMPROMISE FLOW IN THE LEFT INTERNAL CAROTID ARTERY (LICA), SO A 4TH RX ACCULINK STENT WAS PLACED IN THE LICA OVERLAPPING THE STENT AND CORRECTING THE ANGLE OF THE STENT. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ONE DAY POST-PROCEDURE, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9082651

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (1011649-55, LOT # 9061651)| EMBOLIC PROTECTION: RX ACCUNET| HEPARIN| STENT: PROTEGE GOS, EV3 EVER-FLEX| RX ACCULINK (1011342-30, 9091051)