BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 14108160 · Received April 13, 2022

    Report

    Report Number
    2032493-2022-00149
    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. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEVICE MIGRATION AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE. 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 A PRIOR HISTORY OF SUBARACHNOID HEMORRHAGE CAUSED BY RUPTURE OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM PRESENTED FOR WEB TREATMENT OF AN ENLARGING UNRUPTURED BASILAR APEX ANEURYSM. THE POST-DEPLOYMENT NATIVE DIGITAL SUBTRACTION ANGIOGRAM (DSA) DEMONSTRATED ADEQUATE POSITIONING OF THE WEB SL WITHIN THE ANEURYSM. THE POST-DETACHMENT NATIVE DSA, HOWEVER, DEMONSTRATED A CHANGE IN ORIENTATION OF THE DEPLOYED WEB DEVICE CAUSING MILD IMPINGEMENT OF THE LEFT POSTERIOR CEREBRAL ARTERY. A DECISION WAS MADE TO DEPLOY A LVIS STENT TO PROTECT THE LEFT POSTERIOR CEREBRAL ARTERY. THE POST DEPLOYMENT FLAT PANEL CONE- BEAM CT WITH RECONSTRUCTION OF THE LVIS STENT SHOWED THE WEB DEVICE WITHIN THE ANEURYSM AND PATENT LVIS STENT SPANNING FROM THE LEFT POSTERIOR CEREBRAL ARTERY INTO THE BASILAR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637732 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention