BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB LOW PROFILE SL-USA W4-7-3FOR US

    MDR report key: 10405738 · Received August 13, 2020

    Report

    Report Number
    2032493-2020-00205
    Event Type
    Death
    Date Received
    August 13, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 16, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006136
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 WEB WAS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. SEVERAL ANGIOGRAPHIC IMAGES OBTAINED DURING THE WEB IMPLANTATION PROCEDURE WERE PROVIDED. THE IMAGES ARE CONSISTENT WITH THE REPORTED COMPLAINT DETAILS; HOWEVER, IMAGES WERE NOT PROVIDED OF THE ANEURYSM RE-RUPTURE THAT OCCURRED SEVERAL DAYS POST-PROCEDURE. THE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH A SUBARACHNOID HEMORRHAGE (SAH) AND TREATMENT WAS PERFORMED THE SAME DAY FOR A RUPTURED BASILAR TIP ANEURYSM. THE WEB DEVICE WAS PLACED AND A SMALL "ENCROACHMENT" WAS NOTED. FLOW IN THE VESSEL BECAME LIMITED; THEREFORE, A STENT (NOT A MICROVENTION DEVICE) WAS IMPLANTED AT THE NECK OF THE ANEURYSM WITHOUT INCIDENT. THERE WAS NO ACTIVE BLEEDING AFTER TREATMENT OF THE ANEURYSM WITH THE WEB AT THE END OF THE PROCEDURE. THE PATIENT WAS PLACED ON ASPIRIN AND PLAVIX. THE PATIENT WAS ADMITTED TO THE ICU AND THREE (3) DAYS POST-PROCEDURE ON (B)(6) 2020 THE ANEURYSM RUPTURED AGAIN. THE PATIENT DIED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870046 WEB LOW PROFILE SL-USA W4-7-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25070-030 19091211 00854111006136

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R