BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 9310131 · Received November 12, 2019

    Report

    Report Number
    1226348-2019-01020
    Event Type
    Injury
    Date Received
    November 12, 2019
    Report Date
    October 21, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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.  MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION.  INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿FACTORS ASSOCIATED WITH POSTPROCEDURAL DIFFUSION-WEIGHTED IMAGING POSITIVE LESIONS IN ENDOVASCULAR TREATMENT FOR UNRUPTURED CEREBRAL ANEURYSMS KEISUKE. 31 PATIENTS WITH CEREBRAL ANEURYSMS WHO UNDERWENT STENT-ASSISTED COIL EMBOLIZATION WITH STENTS ENTERPRISE EXPERIENCED ASYMPTOMATIC THROMBOEMBOLIC LESIONS DETECTED BY POSTPROCEDURAL DIFFUSION-WEIGHTED IMAGING (DWI). THE AIM OF THIS STUDY WAS TO CLARIFY FACTORS ASSOCIATED WITH POSTPROCEDURAL DWI-POSITIVE LESIONS IN ENDOVASCULAR TREATMENT FOR UNRUPTURED CEREBRAL ANEURYSMS. METHODS: PATIENTS WITH UNTREATED UNRUPTURED CEREBRAL ANEURYSMS UNDERGOING ENDOVASCULAR TREATMENT WERE CONSECUTIVELY ENROLLED. TREATMENT TECHNIQUES WERE CLASSIFIED INTO SIMPLE COILING, BALLOON-ASSISTED COILING, STENT-ASSISTED COILING, AND FLOW-DIVERTER PLACEMENT. HEAD MAGNETIC RESONANCE IMAGING WAS PERFORMED WITHIN 3 MONTHS BEFORE AND 24 HOURS AFTER THE PROCEDURE TO ASSESS THE APPEARANCE OF DWI-POSITIVE LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107181 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other