BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1444873 · Received August 19, 2009

    Report

    Report Number
    3004742046-2009-00200
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE IS BEING HELD BY THE USER FACILITY RISK MANAGEMENT AND WILL NOT BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFO. THE RX ACCUNET (PART #1011343-40, LOT# 9061251) IS BEING FILED UNDER MEDWATCH MFR #3004742046-2009-00199.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: ENTANGLEMENT OF THE EPD WITH THE STENT. SYMPTOMS/AE: SURGICAL REMOVAL. TIME OF MALFUNCTION/AE: DURING AND AFTER THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE NOSE CONE OF THE STENT DELIVERY CATHETER DETACHED AND BECAME STUCK ON THE WIRE DISTAL TO WHERE THE STENT WAS PLACED. THE DETACHMENT WAS NOTICED DURING POST DILATATION OF THE STENT. MULTIPLE UNSUCCESSFUL MANEUVERS WERE ATTEMPTED TO SNARE THE NOSE CONE. THE EMBOLIC PROTECTION DEVICE (EPD) WAS THEN USED TO TRY TO PULL THE DETACHED NOSED CONE THROUGH THE STENT WITH PLANS TO CAPTURE BOTH THE EPD, AND THE DETACHED NOSE CONE WITHIN THE SHEATH; HOWEVER, A THE EPD BECAME ENTANGLED WITH THE STENT. AFTER SEVERAL OTHER UNSUCCESSFUL MANEUVERS, THE PT WAS TAKEN TO SURGERY FOR RETRIEVAL OF THE NOSE CONE, FILTER AND STENT. THERE WAS NO ADVERSE PT SEQUELA REPORTED. TWO DAYS 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 ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9050551

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention HEPARIN| SHUTTLE SHEATH 7F| JR4 GUIDE CATH| RX ACCULINK STENT (PART# 1011343-40