BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3033283 · Received April 3, 2013

    Report

    Report Number
    3008853977-2013-00058
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    August 1, 2006
    Report Date
    March 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PATIENTS WERE TREATED BETWEEN AUGUST 2006 AND AUGUST 2009, THE EXACT DATE OF THE PROCEDURE FOR THIS EVENT IS UNKNOWN. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT OUTCOME OF DEATH AND HEMMORHAGE ARE NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EXECUTIVE SUMMARY - CORRECTED; PRODUCT CODE - CORRECTED; COMMON DEVICE NAME - CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT FOLLOWING STENT PLACEMENT IN THE TARGET LESION, THE PATIENT SUFFERED A PERIPROCEDURAL ISCHEMIC STROKE THAT RESULTED IN DEATH. THE EXACT PROCEDURE OR DEATH DATE ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT FOLLOWING A SECOND ANGIOPLASTY TO TREAT THE TARGET LESION, THE PATIENT SUFFERED A PERIPROCEDURAL SUBARACHNOID HEMORRHAGE THAT RESULTED IN DEATH. THE EXACT PROCEDURE OR DEATH DATE ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT FOLLOWING A SECOND ANGIOPLASTY TO TREAT THE TARGET LESION, THE PATIENT SUFFERED A PERIPROCEDURAL SUBARACHNOID STROKE THAT RESULTED IN DEATH. THE EXACT PROCEDURE OR DEATH DATE ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137315 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death