BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB SL 17 SINGLE LAYER W5-4-3

    MDR report key: 8952728 · Received August 30, 2019

    Report

    Report Number
    2032493-2019-00204
    Event Type
    Death
    Date Received
    August 30, 2019
    Date of Event
    December 9, 2019
    Report Date
    August 8, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006259
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT NOTES THAT INCLUDED FLUOROSCOPIC IMAGES AND VASCULAR DIMENSIONS WERE PROVIDED AND REVIEWED. THE INFORMATION WAS CONSISTENT WITH THE COMPLAINT, THE INITIAL INJURY TO THE PATIENT, AND THE PATIENT CAUSE OF DEATH. THE REVIEWED CONTENT DID NOT CONTAIN INFORMATION OR IMAGES THAT CONFLICTED WITH THE COMPLAINT DESCRIPTION. THE DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ELECTIVE COILING OF AN ANTERIOR COMMUNICATION ARTERY (ACOM) AND BASILAR TIP ANEURYSM. A WEB DEVICE WAS PLACED FOR THE BASILAR TIP ANEURYSM; HOWEVER, THIS MIGRATED WHICH CAUSED A BRAINSTEM STROKE. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY, HOWEVER, THE PATIENT PASSED AWAY FOLLOWING A SUBARACHNOID HEMORRHAGE AND MID-BRAIN INFARCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744092 WEB SL 17 SINGLE LAYER W5-4-3 WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FG29040-030 17121507 00854111006259

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death