BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 8769935 · Received July 8, 2019

    Report

    Report Number
    1226348-2019-00930
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    December 31, 2018
    Report Date
    June 17, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). CONTACT OFFICE: CODMAN AND SHURTLEFF, INC (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿EXTENDING THE INDICATION OF WOVEN ENDOBRIDGE (WEB) EMBOLIZATION TO INTERNAL CAROTID ARTERY ANEURYSMS: A MULTICENTER SAFETY AND FEASIBILITY STUDY.¿ A (B)(6) YEAR-OLD FEMALE PATIENT WITH UNRUPTURED INTERNAL CAROTID ARTERY ANEURYSM WHO UNDERWENT ENTERPRISE STENT DEPLOYMENT DEVELOPED ASYMPTOMATIC IN-STENT STENOSIS AT FOLLOW-UP. THE PATIENT WAS ASYMPTOMATIC AND NO FURTHER INTERVENTIONS WERE REQUIRED. OBJECTIVE: THIS STUDY EVALUATE THE SAFETY AND EFFICACY OF WOVEN ENDOBRIDGE (WEB) EMBOLIZATION TO INTERNAL CAROTID ARTERY ANEURYSMS. METHODS: PATIENTS WITH ICA SIDEWALL ANEURYSMS WHO WERE TREATED WITH WEB AT 3 GERMAN NEUROVASCULAR CENTERS WERE REVIEWED BETWEEN 2011 AND 2018. TECHNICAL SUCCESS, COMPLICATION RATES, AND ANGIOGRAPHIC OUTCOME WERE RETROSPECTIVELY ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562821 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other