BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 9905362 · Received March 31, 2020

    Report

    Report Number
    1226348-2020-00029
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    March 10, 2020
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 AFFECTING THE DEGREE OF ANGULAR REMODELING IN STENT-ASSISTED COILING OF BIFURCATION ANEURYSMS¿. 2 PATIENTS WITH BASILAR OR CAROTID BIFURCATION ANEURYSMS TREATED BY STENT-ASSISTED COILING (SAC) EXPERIENCED RECANALIZATION. PURPOSE: TO STUDY THE FACTORS CONTRIBUTING TO ANGULAR REMODELING FOLLOWING SAC OF BIFURCATION ANEURYSMS INCLUDING THE ANATOMICAL, STENT-RELATED, AND COIL-RELATED FACTORS METHODS: WE REVIEWED 43 BASILAR AND CAROTID BIFURCATION ANEURYSMS TREATED BY SAC USING NEUROFORM EZ (N = 28), ENTERPRISE (N = 8), AND LVIS JR. (N = 7) STENTS. THE BIFURCATION ANGLE BETWEEN THE MOTHER AND STENTED DAUGHTER VESSEL WAS MEASURED IN 4 SETTINGS: PRETREATMENT, POST STENTING, POST COILING, AND DELAYED FOLLOW-UP (6¿12 MONTHS). CERENOVUS DEVICES (ENTERPRISE (N = 8),) WERE USED IN THIS STUDY. NO DEVICES SPECIFIC INFORMATION (INCLUDING CATALOG AND THE LOT NUMBER) WERE PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368302 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other