BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SLS 27 SINGLE LAYER

    MDR report key: 8571727 · Received May 1, 2019

    Report

    Report Number
    2032493-2019-00113
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 2, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00851566003338
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH THE DELIVERY WIRE AND A DETACHED WEB. THE WEB WAS INSPECTED UNDER MAGNIFICATION AND FOUND TO HAVE A SMALL PIECE OF TETHER STILL INTACT. THIS TETHER DID NOT DISPLAY ANY SIGNS OF MELTING FROM A DEPLOYMENT SIGNAL FROM A WDC, AND IT IS TOO LONG FOR THE TYPICAL MELT POINT OF THE TETHER. THE TETHER APPEARS TO HAVE BEEN BROKEN DUE TO A SHEAR/KINK BREAK. THE FLUOROSCOPIC IMAGES PROVIDED TO MICROVENTION SHOW THE WEB DEVICE BEING RETRIEVED WITH A SNARE; THE IMAGES DO NOT APPEAR TO SHOW THE WEB BEING PLACED IN THE ANEURYSM OR THE WEB DEVICE'S PREMATURE DETACHMENT. BASED ON THE EVALUATION OF THE RETURNED WEB DEVICE, THE REPORTED COMPLAINT OF A PREMATURE DETACHMENT IS CONFIRMED. THE DETACHMENT MONOFILAMENT WAS FOUND TO BE BROKEN WITH A PROFILE THAT IS CONSISTENT WITH A SHEAR OR KINK. THE PHYSICAL EVALUATION OF THE RETURNED PRODUCT COULD NOT DEFINITIVELY DETERMINE WHAT CAUSED THE KINK OR SHEARING FORCE, BUT IT IS CONSISTENT WITH THE WEB SYSTEM EXPERIENCING FORCES OVER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORDS INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DELIVERY INTO THE ANEURYSM, THE WEB WAS PROTRUDING INTO THE CAROTID ARTERY. THE WEB WAS RETRACTED TO ACHIEVE BETTER POSITIONING IN THE ANEURYSM; HOWEVER, DURING THE ATTEMPT, THE DELIVERY WIRE DETACHED FROM THE WEB. THE CAROTID ARTERY WAS ALMOST 90% OCCLUDED BY THE PROXIMAL SEGMENT OF THE WEB. A SNARE DEVICE WAS USED TO CAPTURE THE DEVICE MARKER AND RETRIEVE THE WEB SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED THE DAY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363548 WEB SLS 27 SINGLE LAYER WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FG15090-001 18081414 00851566003338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention