BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1344226 · Received March 13, 2009

    Report

    Report Number
    3004742046-2009-00048
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 17, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY REPORT. THE RX ACCUNET EMBOLIC PROTECTION DEVICE LOT 8120551, IS BEING FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2009-00047. EVALUATION SUMMARY: THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. THE RX ACCULINK STENT IS AN OPEN CELL STENT STRUT DESIGN THAT ALLOWS FOR INDEPENDENT RING EXPANSION. THE VESSEL WAS REPORTED TO BE HEAVILY CALCIFIED WHICH MAY HAVE OBSTRUCTED A RING FROM FULL EXPANSION IN COMPARISON TO THE ADJACENT STENT RINGS. THIS WOULD LEAD TO THE APPEARANCE OF THE REPORTED "FISH SCALING" ON THE STENT. THE AVAILABLE INFORMATION DOES NOT SUGGEST THAT THERE WAS A DEVICE QUALITY ISSUE BUT RATHER THE PROCEDURAL CIRCUMSTANCES OF THE CASE CONTRIBUTED TO THE EVENT. ADDITIONALLY, A CD WITH ANGIOGRAPHIC RUNS AND STILL IMAGES WAS PROVIDED AND REVIEWED. CONTRARY TO THE REPORTED COMPRESSION OF THE PROXIMAL SEGMENT OF THE ACCULINK STENT, IT WAS DETERMINED THAT THE DISTAL END OF THE ACCULINK STENT WAS INVAGINATED. DURING MANUFACTURING, THE RX ACCULINK STENT IS 100% VISUALLY INSPECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULTY RECOVERING THE FILTER. SYMPTOMS / AE: PLACEMENT OF A SECOND ADDITIONAL STENT. TIME OF MALFUNCTION/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THERE WAS DIFFICULTY RETRIEVING THE EMBOLIC PROTECTION DEVICE. NEITHER THE "SHAPEABLE TIP DESIGN (RC1) OR THE "LOW PROFILE FLEXIBLE" DESIGN (RC2) COULD PASS THROUGH THE OPEN CELL DESIGN OF THE RX ACCULINK STENT DUE TO 'FISH SCALING' IN THE MID PORTION OF THE STENT. MULTIPLE PATIENT MANEUVERS WERE ATTEMPTED AND SEVERAL OTHER DEVICES WERE ATTEMPTED TO HELP PASS THE RETRIEVAL DEVICE THROUGH THE STENT, BUT ALL WERE UNSUCCESSFUL. AN XACT STENT WAS THEN PLACED INSIDE THE 'FISH SCALED' PORTION OF THE STENT ALLOWING RC2 TO CROSS THROUGH THE STENT AND SUCCESSFULLY CAPTURE THE FILTER. IT WAS ALSO NOTED THAT THERE WAS SOME INVAGINATION OF THE PROXIMAL END OF THE RX ACCULINK STENT, ALTHOUGH ANGIOGRAPHICALLY THERE APPEARED TO BE PATENCY OF THE VESSEL WITH NO EVIDENCE OF DISTAL EMBOLIZATION, SLOW FLOW OR SPASM. THERE WAS NO ADVERSE PATIENT SEQUELAE REPORTED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8120251

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention LOT 8120551| HEPARIN| RX ACCUNET EMBOLIC PROTECTION DEVICE