BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SINGLE LAYER-USA W2-8-4FOR US

    MDR report key: 10312043 · Received July 22, 2020

    Report

    Report Number
    2032493-2020-00174
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00856956005817
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE WEB IMPLANT WAS RETURNED DETACHED FROM THE DELIVERY SYSTEM. THE WEB WAS NOT NOTABLY DAMAGED AND THE DETACHMENT ZONE DID NOT DISPLAY ANY ABNORMALITIES. A KINK WAS OBSERVED AT THE EPOXY JOINT BETWEEN THE HYPOTUBE AND GOLD CONNECTORY. THE REST OF THE DELIVERY SYSTEM AND THE DISTAL TIP DID NOT DISPLAY ANY NOTABLE DAMAGE. THE CONNECTOR SOLDER JOINTS APPEARED INTACT; HOWEVER, RESISTANCE WAS MEASURED AT "OL." THE MICROCATHETER USED WAS RETURNED AND HAD PINCHES 5 CM, 6 CM AND A SMASHED SEGMENT FROM 8 CM TO 9CM FROM THE DISTAL TIP OF THE CATHETER. THE RETURNED WDC ACTIVATES NORMALLY AND CAN SUCCESSFULLY DETACH A WEB. TO EXAMINE HEATER COIL OF THE DELIVERY SYSTEM, THE SYSTEM WAS INTENTIONALLY BROKEN AT AN AREA DISTAL TO THE HYPOTUBE/GOLD CONNECTOR JUNCTION, AND THE CORE WIRE WAS REMOVED FROM THE SYSTEM. THE PET OF THE HEATER COIL HAD SIGNS OF HEAT DAMAGE, AND A COIL FROM THE HEATER COIL WAS HANGING OUTSIDE OF THE TIP OF THE STRAIN RELIEF. THE WEB MOST LIKELY WAS DETACHED BY THE WEB DETACHMENT CONTROLLER (WDC), AS INDICATED IN THE COMPLAINT DESCRIPTION; HOWEVER, EVIDENCE FROM THE HEATER COIL SUGGESTS THAT THE WEB MAY HAVE HAD SOME INTERACTIONS WITH THE DISTAL COILS THAT RESULTED IN THE WEB STICKING TO THE PUSHER POST WDC ACTIVATION, BUT THIS CANNOT BE CONFIRMED WITH ABSOLUTE CERTAINTY BASED ON THE PHYSICAL EVALUATION OF THE DEVICE ALONE. THE ASSOCIATED VIA MICROCATHETER WAS ALSO RETURNED WITH SOME DAMAGED SEGMENTS, BUT IT IS UNCLEAR WHEN THE DAMAGE OCCURRED OR IF THE DAMAGE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE DEVICE DETACHMENT AND DIFFICULT DEVICE DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, THE WEB DID NOT DETACH AFTER TWO (2) ATTEMPTS. THE WEB APPEARED TO HAVE DETACHED WITH THE THIRD ATTEMPT; HOWEVER, WHEN THE PUSHER WIRE AND MICROCATHETER WERE REMOVED, THE WEB WAS PULLED OUT OF THE ANEURYSM AND THEN DETACHED IN THE INTERNAL CAROTID ARTERY (ICA). THE WEB WAS REMOVED FROM THE ICA WITH A STENT RETRIEVER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO HAVE NO DEFICIENCIES THE DAY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775868 WEB SINGLE LAYER-USA W2-8-4FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC FGA15080-040 19081425 00856956005817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention