BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 14108159 · Received April 13, 2022

    Report

    Report Number
    2032493-2022-00150
    Event Type
    Injury
    Date Received
    April 13, 2022
    Report Date
    March 29, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD AND NON-CONFORMANCES COULD NOT BE PERFORMED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. BIBLIOGRAPHY: GOYAL, NITIN, ET AL. "HOW TO WEB: A PRACTICAL REVIEW OF METHODOLOGY FOR THE USE OF THE WOVEN ENDOBRIDGE." JOURNAL OF NEUROINTERVENTIONAL SURGERY 12.5 (2020): 512-520.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE ARTICLE TITLED, "HOW TO WEB: A PRACTICAL REVIEW OF METHODOLOGY FOR THE USE OF THE WOVEN ENDOBRIDGE", A PATIENT WITH AN INCIDENTAL BASILAR APEX ANEURYSM PRESENTED FOR ELECTIVE WEB TREATMENT. IMMEDIATE POST­DEPLOYMENT DIGITAL SUBTRACTION ANGIOGRAM (DSA) DEMONSTRATED ADEQUATE DEPLOYMENT OF THE WEB WITHIN THE ANEURYSM. DURING THE SIX- MONTH FOLLOW- UP, THE DSA SHOWED WEB COMPRESSION AND NECK REMNANT. TWO- YEAR FOLLOW- UP DSA SHOWED GROWING NECK REMNANT. THE DECISION WAS MADE TO PROCEED WITH STENT-ASSISTED COILING OF THE NECK REMNANT. IMMEDIATE POST- RETREATMENT NATIVE DSA DEMONSTRATED A COIL MASS WITHIN THE NECK REMNANT AND STENT SPANNING FROM THE LEFT POSTERIOR CEREBRAL ARTERY INTO THE BASILAR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637731 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention