BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2192777 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05533
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, LACK OF GUIDE CATHETER SUPPORT, INTERACTION BETWEEN ASSOCIATED DEVICES, NOT USING THE BARE WIRE FILTER DELIVERY WIRE OR EXCESSIVE EMBOLI IN THE FILTER ELEMENT. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY RETRIEVING THE FILTER WAS DUE TO THE FILTER ELEMENT BEING FULL OF EMBOLI DEBRIS. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBERS WERE NOT REPORTED. BASED ON THE REPORTED INFORMATION, THE DIFFICULTY APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE FEMORAL ARTERY, AN EMBOSHIELD NAV6 EMBOLIC PROTECTION FILTER WAS DEPLOYED. AFTER ATHERECTOMY WAS PERFORMED, THE FILTER WAS FULL OF DEBRIS AND COULD NOT BE COMPLETELY PULLED INTO THE RETRIEVAL CATHETER. AN ATTEMPT WAS MADE TO PULL THE FILTER AND RETRIEVAL CATHETER AS A SINGLE UNIT INTO THE SHEATH BUT DUE TO THE DEBRIS IN THE FILTER, THE ATTEMPT WAS UNSUCCESSFUL. AN UNSPECIFIED BUDDY WIRE WAS ADVANCED INTO THE ANATOMY FOR ADDITIONAL SUPPORT. AN ATTEMPT WAS MADE TO PULL THE SHEATH, RETRIEVAL CATHETER AND FILTER AS A SINGLE UNIT; HOWEVER, THE PHYSICIAN RELEASED THE UNIT TO GET A BETTER GRIP, AND ONLY THE SHEATH WAS WITHDRAWN INSTEAD OF THE ENTIRE UNIT. THE FILTER AND RETRIEVAL CATHETER WERE SECURED WITH HEMOSTATS AND REMOVED FROM THE ANATOMY SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT; HOWEVER, A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention