BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 9286520 · Received November 6, 2019

    Report

    Report Number
    1226348-2019-01016
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    July 31, 2018
    Report Date
    October 15, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION RELATED TO THE LITERATURE PUBLICATION ENTITLED, ¿APPLICATION OF HIGH-RESOLUTION C-ARM CT COMBINED WITH STREAK METAL ARTIFACT REMOVAL TECHNOLOGY FOR THE STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSMS¿ THE ARTICLE WAS REREVIEWED 2 PATIENTS WITH INTRACRANIAL ANEURYSMS WHO UNDERWENT STENT-ASSISTED EMBOLIZATION DEVELOPED SUBACUTE HYDROCEPHALUS DURING THE FOLLOW-UP PERIOD (MRS SCORES OF 2 AND 3, RESPECTIVELY) CAUSED BY NONANEURYSMAL ARTERY STENOSIS. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION OR THAT THE EVENT WAS RELATED TO THE PROCEDURE. THUS THE EVENT IS ESTIMATED AS RELATED TO THE PREEXISTED CONDITION AND DOES NOT MEET MDR REPORTABILITY CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). (B)(6). 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 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. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2019-01014, 1226348-2019-01015, 1226348-2019-01016, 1226348-2019-01017

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿APPLICATION OF HIGH-RESOLUTION C-ARM CT COMBINED WITH STREAK METAL ARTIFACT REMOVAL TECHNOLOGY FOR THE STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSMS¿ 2 PATIENTS WITH INTRACRANIAL ANEURYSMS WHO UNDERWENT STENT-ASSISTED EMBOLIZATION EXPERIENCED SUBACUTE HYDROCEPHALUS THE GOAL OF THIS STUDY WAS TO EVALUATE THE UTILITY OF HIGH-RESOLUTION C-ARM CT COMBINED WITH STREAK METAL ARTIFACT REMOVAL TECHNOLOGY FOR STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSMS. MATERIALS AND METHODS: FROM OCTOBER 2017 TO JULY 2018, THE FIRST AFFILIATED HOSPITAL OF (B)(6) UNIVERSITY TREATED 107 PATIENTS WITH INTRACRANIAL ANEURYSMS (118 ANEURYSMS IN TOTAL) WITH STENT ASSISTED EMBOLIZATION. CONVENTIONAL C-ARM CT AND HIGH-RESOLUTION C-ARM CT SCANNING OF THE STENTED AREA WERE PERFORMED DURING AND AFTER TREATMENT. 3D IMAGES WERE RECONSTRUCTED WITH AND WITHOUT STREAK METAL ARTIFACT REMOVAL TECHNIQUES. SUBSEQUENTLY, THE IMAGE QUALITY WAS COMPARED. THE RECONSTRUCTED IMAGES INDICATED THE STENT DEPLOYMENT DEGREE AND PACKING DENSITY. FOLLOW-UP ASSESSMENTS INCLUDED CLINICAL AND ANGIOGRAPHIC OUTCOMES AND COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080403 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other