BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS JR 3.5X23MM

    MDR report key: 8097833 · Received November 21, 2018

    Report

    Report Number
    2032493-2018-00254
    Event Type
    Death
    Date Received
    November 21, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    UDI-DI
    00810170018589
    PMA / PMN Number
    K130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 STENT WAS IMPLANTED IN THE PATIENT AND THE REMAINDER OF THE DEVICE WAS DISCARDED AT THE USER FACILITY; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE ROOT CAUSE IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE OR PERFORATION OF ANEURYSM, HEMORRHAGING, AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, TREATMENT WAS PERFORMED FOR AN ACUTE RUPTURED ANEURYSM IN THE A1/2 ARTERY. PRIOR TO THE PROCEDURE, THE PATIENT WAS ASSESSED PER SAH GRADING SCALES AS CLASSEN GRADE IV AND HUNT AND HESS 5, AND VENTRICULAR DRAINAGE WAS PERFORMED. DURING DEPLOYMENT, THE STENT OPENED SUCCESSFULLY DISTALLY AND PROXIMALLY TO THE ANEURYSM IN AN S-SHAPED CURVE (FROM RIGHT A2 TO A1). THE STENT WAS REPORTED TO HAVE BEEN OVERSIZED. THE STENT WAS INTENTIONALLY RELEASED WITH THE BELIEF THAT THE MIDDLE SECTION WOULD EVENTUALLY OPEN. ATTEMPTS WERE MADE TO OPEN THE MIDDLE SECTION WITH A MICROCATHETER AND A BALLOON; HOWEVER, THEY WERE UNSUCCESSFUL. THE VESSEL WAS REPORTED TO BE OKAY WITHOUT EVIDENCE OF THROMBUS FORMATION POST STENT DEPLOYMENT. THE ANEURYSM WAS 7MM AND 4MM NECK TO DOME DISTANCE AND WAS IMPOSSIBLE TO COIL WITHOUT SOME NECK PROTECTION; THEREFORE, THE PLANNED COIL EMBOLIZATION WAS NOT ABLE TO BE PERFORMED AND THERE WERE NO OTHER OPTIONS FOR TREATMENT. THE PATIENT WAS TAKEN TO THE ICU AND WAS DETERMINED TO BE BRAIN DEAD APPROXIMATELY 30 MINUTES AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE ANEURYSM WAS MOST LIKELY PUNCTURED DURING RECANALIZATION ATTEMPTS. THE OFFICIAL CAUSE OF DEATH WAS "BRAIN DEATH DUE TO INTRAOPERATIVE ANEURYSM RUPTURE." AS OF (B)(6) 2018, THE PATIENT IS BRAIN DEAD IN THE ICU AND IS OFFERED AS AN ORGAN DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934072 LVIS JR 3.5X23MM STENT NJE MICROVENTION, INC. 172524-CASJ 18052253C 00810170018589

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| L| R