BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 963662 · Received December 11, 2007

    Report

    Report Number
    3004742046-2007-00385
    Event Type
    Injury
    Date Received
    December 11, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 12, 2007
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:THE STENT REMAINS IN THE PT. THE STENT DELIVERY SYSTEM WAS RETURNED. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE ACCULINK TIP HAD MATED WITH THE PROXIMAL BUSHING OF THE ACCUNET. THE ACCUNET "INSTRUCTIONS FOR USE" STATES THAT PROPER POSITIONING OF THE FILTER BASKET IS APPROXIMATELY 4 CM DISTAL TO THE LESION. IF THE ACCUNET IS NOT HELD 4CM DISTAL TO THE TARGET LESION. IF THE ACCUNET IS NOT HELD 4CM DISTAL TO THE TARGET LESION, IT IS POSSIBLE FOR THE TIP OF THE ACCULINK TO GET STUCK TO THE ACCUNET. THIS IN TURN COULD CAUSE THE ACCULINK TIP TO DETACH UPON WITHDRAWAL OF THE SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE RX ACCUNET PART #1011649-55, LOT #7020851, IS BEING FILED UNDER MEDWATCH MFR #3004742046-2007-00384.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CATHETER TIP DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT AFTER A REVASCULARIZATION STENTING PROCEDURE IN A HEAVILY CALCIFIED INTERNAL CAROTID ARTERY, THE TIP OF THE STENT DELIVERY CATHETER DETACHED AND REMAINED ON THE EMBOLIC PROTECTION DEVICE GUIDE WIRE. THE CATHETER TIP WAS REMOVED WITH A SHEATH 6FR. SHEATH. ALTHOUGH NO RESISTANCE WAS FELT, THE PHYSICIAN BELIEVED THE CATHETER ADVANCED OVER THE FILTER BASKET BUSHINGS CAUSING THE TIP DETACHMENT. ADDITIONALLY, ATTEMPTS TO RETRIEVE THE EMBOLIC PROTECTION DEVICE WITH BOTH RETRIEVAL CATHETERS WERE NOT SUCCESSFUL. THE FILTER BASKET WAS REMOVED USING A 6FR. SHEATH. THERE WERE NO REPORTED PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6072451

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention RX ACCUNET