BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 8782253 · Received July 11, 2019

    Report

    Report Number
    1226348-2019-00949
    Event Type
    Death
    Date Received
    July 11, 2019
    Date of Event
    January 31, 2017
    Report Date
    June 20, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CORRECTION OF THE PREVIOUS SUBMISSION REPORT RELATED TO THE LITERATURE ARTICLE ENTITLED ¿FORWARD DEPLOYED COIL EMBOLIZATION WITH MULTIPLE OVERLAPPING STENTS FOR RUPTURED BLOOD BLISTERLIKE ANEURYSMS: TECHNICAL CONSIDERATIONS AND OUTCOMES". THE PRODUCT CODE WAS UPDATED FROM UNKENTERPRISEENC TO UNKENTERPRISEENF.

    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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿FORWARD DEPLOYED COIL EMBOLIZATION WITH MULTIPLE OVERLAPPING STENTS FOR RUPTURED BLOOD BLISTER-LIKE ANEURYSMS: TECHNICAL CONSIDERATIONS AND OUTCOMES¿. A (B)(6) FEMALE PATIENT WITH BLOOD BLISTER¿LIKE ANEURYSM (BBA) WHO UNDERWENT STENT ASSISTED COIL EMBOLIZATION DEAD FROM A COMPLICATION OF END-STAGE RENAL DISEASE (ESRD) ON 3 WEEKS AFTER TREATMENT. OBJECTIVE: DESCRIBE A SAFE DENSE COIL PACKING TECHNIQUE INTO AND JUST PROXIMAL OF BBAS USING A SEMI-JAILING TECHNIQUE FOR THE TREATMENT OF BBAS OF THE INTERNAL CAROTID ARTERY (ICA) AND REPORT THE LONG-TERM CLINICAL OUTCOMES. SEVENTEEN PATIENTS, 7 MEN AND 10 WOMEN, WERE TREATED BY FORWARD DEPLOYMENT OF COILS UNDER MULTIPLE OVERLAPPING STENTING FROM SEPTEMBER 2008 THROUGH AUGUST 2017. PATIENTS¿ AGES RANGED FROM 27 TO 73 YEARS (MEAN 47.9 ± 11 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573645 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death