BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2964051 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00899
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DE NOVO, MODERATELY CALCIFIED, 70% STENOSED, RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AN ACCULINK STENT WAS IMPLANTED AND THERE WAS DIFFICULTY WITH THE RECOVERY CATHETER ENGULFING THE DISTAL FILTER FOR REMOVAL DUE TO THE PATIENTS ANATOMY. THE ACCUNET SHAPEABLE TIP RETRIEVAL DEVICE WAS SUCCESSFULLY USED TO RECOVER THE DISTAL PROTECTION DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66206 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2011361

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention STENT: RX ACCULINK 7-10 X 40