BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 12628883 · Received October 13, 2021

    Report

    Report Number
    2024168-2021-09211
    Event Type
    Death
    Date Received
    October 13, 2021
    Date of Event
    January 1, 2014
    Report Date
    November 18, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NTE
    PMA / PMN Number
    K141678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: AVERAGE. SEX: MAJORITY. ESTIMATED. LITERATURE, TITLE: ¿POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT ABBOTT CAROTID STENT AND EMBOLIC PROTECTION SYSTEMS¿. THE DEVICE(S) ARE NOT RETURNING. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE UDI IS UNKNOWN AS THE SPECIFIC PART/LOT NUMBER(S) ARE UNKNOWN. THE ADDITIONAL PATIENT EFFECTS AND ABBOTT DEVICES, ALONG WITH DEVICE ISSUES, REFERENCED IN THE ATTACHED ARTICLE, ARE CAPTURED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    THE POST-MARKET CLINICAL FOLLOW-UP (PMCF) REPORT, TITLED ¿POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT ABBOTT CAROTID STENT AND EMBOLIC PROTECTION SYSTEMS¿ EVALUATED THE SAFETY AND PERFORMANCE OF THE RX ACCULINK AND X.ACT CAROTID STENT SYSTEM (CSS) AND THE EMBOSHIELD NAV 6 AND RX ACCUNET EMBOLIC PROTECTION SYSTEM (EPS). IT WAS REPORTED THROUGH THE PMCF REPORT THAT THE EMBOSHIELD NAV 6 MAY BE RELATED TO DEATH. ALTHOUGH THE ABOVE ADVERSE EVENTS WERE NOTED, IN CONCLUSION, THE OVERALL ANALYSES FROM THIS STUDY DEMONSTRATES THAT THE USE OF THE EMBOSHIELD NAV 6 MET THE SAFETY AND PERFORMANCE CRITERIA. THIS PMCF REPORTS THE ABBOTT DEVICES ARE SIMILAR TO COMPETITOR DEVICES AND ARE WITHIN STATE-OF-ART. THE ABBOTT DEVICES HAVE COMPARABLE SAFETY AND PERFORMANCE ISSUES WHEN USING VERSUS COMPETITOR DEVICES. THE OVERALL RESIDUAL RISK OF DEVICE USE IS ACCEPTABLE. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE PMCF REPORT TITLED ¿POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT ABBOTT CAROTID STENT AND EMBOLIC PROTECTION SYSTEMS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523669 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death