BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 8760252 · Received July 3, 2019

    Report

    Report Number
    1226348-2019-00922
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    November 30, 2018
    Report Date
    June 11, 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 · 1

    PRODUCT COMPLAINT #: (B)(4). MFR SITE: 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.  THIS IS ONE OF SEVEN PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2019-00925, 1226348-2019-00926, 1226348-2019-00927, 1226348-2019-00928, 1226348-2019-00923, 1226348-2019-00924.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿THIRTY-DAY OUTCOMES OF ENTERPRISE STENT IN TREATING HYPOPERFUSION OF SYMPTOMATIC INTRACRANIAL STENOSIS¿. A PATIENT WITH SYMPTOMATIC SEVERE INTRACRANIAL STENOSIS WHO UNDERWENT ENTERPRISE STENT DEPLOYMENT DEVELOPED ISCHEMIC STROKE. OBJECTIVE THIS STUDY AIMED TO EVALUATE THE 30-DAY OUTCOMES OF ENTERPRISE STENT IN TREATING PATIENTS WITH HYPOPERFUSION OF SYMPTOMATIC SEVERE INTRACRANIAL STENOSIS. METHODS PATIENTS WITH SYMPTOMATIC SEVERE INTRACRANIAL STENOSIS (70%¿99%) WHO UNDERWENT ENTERPRISE STENT INTERVENTION FROM AUGUST 2014 TO NOVEMBER 2018 WERE RETROSPECTIVELY ANALYZED. THE 30-DAY PRIMARY OUTCOMES INCLUDED THE SUCCESS RATE OF STENTING AND THE INCIDENCE OF COMPLICATIONS, INCLUDING ISCHEMIC STROKE, CEREBRAL HEMORRHAGE, AND DEATH. THE 30-DAY COMPLICATION RATES OF PATIENTS WITH. DIFFERENT LESION LOCATIONS AND CLASSIFICATIONS OF MORI MORPHOLOGY WERE COMPARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551621 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other