BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 11665305 · Received April 14, 2021

    Report

    Report Number
    2183870-2021-00142
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    February 1, 2021
    Report Date
    April 14, 2021
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: OUTCOMES OF CAROTID REVASCULARIZATION VERSUS OPTIMAL MEDICAL TREATMENT ALONE FOR ASYMPTOMATIC CAROTID STENOSIS: INVER SE-PROBABILITY-OF-TREATMENT WEIGHTING USING PROPENSITY SCORES JIHEE KANG, YOUNG-WOOK KIM, DONG-IK KIM, SHIN-YOUNG WOO, YANG-JIN PARK3 WORLD NEUROSURG. (2021) 146:E419-E430. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.10.104. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A RETROSPECTIVE ANALYSIS OF PATIENTS WITH ASYMPTOMATIC SEVERE CAROTID STENOSIS OVER A 23-YEAR PERIOD. 1089 PATIENTS WERE INCLUDED IN THE RETROSPECTIVE ANALYSIS. MEDTRONIC¿S SPIDER FX EMBOLIC PROTECTION DEVICE WAS IDENTIFIED AS BEING USED IN SOME CAROTID ARTERY STENTING (CAS) PROCEDURES. THE ENDPOINT WAS DEFINED AS A COMPOSITE OF ANY STROKE, MYOCARDIAL INFARCTION, AND DEATH WITHIN 30 DAYS AFTER TREATMENT INITIATION, PLUS IPSILATERAL STROKE THEREAFTER. MEAN FOLLOW-UP WITHIN THE CAS GROUP WAS 3.7 YEARS. WITHIN THE CAS GROUP COMPLICATIONS OF STROKE WITHIN 30 DAYS, AND IPSILATERAL STROKE THEREAFTER ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561757 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR