BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1052563 · Received May 22, 2008

    Report

    Report Number
    3004742046-2008-00116
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ACCULINK SOFT TIP WAS RETUNED ON A NON-ABBOTT GUIDE WIRE. THE DETACHED TIP WAS LOOSE ON THE GUIDE WIRE AND LOCATED AT THE DISTAL END OF THE GUIDE WIRE. THE ACCULINK SOFT TIP WAS SEPARATED AND DETACHED AT THE GUIDE WIRE LUMEN PROXIMAL TO THE DISTAL MARKER BAND. THE GUIDE WIRE LUMEN FRACTURE FACE WAS JAGGED. THERE WERE TWO KINKS IN THE FILTER GUIDE WIRE DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THERE WAS NO OTHER DAMAGE NOTED. VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE ACCULINK GUIDE WIRE LUMEN REVEALED THE POINT OF FAILURE APPEARS TO BE TENSILE OVERLOAD AT THE GUIDE WIRE LUMEN. THE ACCULINK INSTRUCTIONS FOR USE (IFU) RECOMMENDS USING A RHV WITH AN OPENING GREATER THAN 0.096". THE ACCULINK IFU SUGGEST THAT THE DELIVERY SYSTEM BE RE-SHEATHED BEFORE REMOVAL. IF THE SYSTEM IS NOT RE-SHEATHED, IT IS POSSIBLE FOR THE FLANGE ON THE TIP TO GET CAUGHT DURING REMOVAL. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE GUIDE WIRE LUMEN BREAK; HOWEVER, IT DOES NOT APPEAR TO BE A DEVICE QUALITY ISSUE. THE ACCULINK IS 100% VISUALLY INSPECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOTO REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SDS TIP DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER THE NON-ABBOTT EMBOLIC PROTECTION DEVICE (EPD) WAS POSITIONED DISTAL TO THE TARGET LESION, THE RX ACCULINK STENT WAS UNEVENTFULLY DEPLOYED. THE PHYSICIAN HEARD A "POP/CLICK" NOISE AND RESISTANCE WAS FELT, NEAR THE ROTATING HEMOSTATIC VALVE, DURING THE STENT DELIVERY SYSTEM (SDS) RETRIEVAL ATTEMPT. EXAMINATION OF THE SDS AFTER REMOVAL NOTED THE SOFT TIP WAS DETACHED AND MISSING. A DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE AND POST-DILATATION WAS PERFORMED. UNDER FLUOROSCOPY AND "OLIVE SHAPED OBJECT" LOCATED ON THE GUIDE WIRE WAS OBSERVED. THE DETACHED TIP WAS REMOVED ON THE EPD WIRE THROUGH THE SHEATH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6080251

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR SHEATH: COOK SHUTTLE SHEATH| GUIDE WIRE: BOSTON SCIENTIFIC FILTER