BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS

    MDR report key: 21990692 · Received May 8, 2025

    Report

    Report Number
    2032493-2025-90145
    Event Type
    Injury
    Date Received
    May 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    PMA / PMN Number
    P170013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. THIS IS REPORT 1 OF 3. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE ATTACHED LITERATURE ARTICLE TITLED, "FLOW DIVERSION FOR ACUTELY RUPTURED INTRACRANIAL ANEURYSMS: A SINGLE-CENTER RETROSPECTIVE ANALYSIS OF 30 CONSECUTIVE CASES", THREE PATIENTS (PATIENT#1, PATIENT#2 AND PATIENT#3) EXPERIENCED POSTPROCEDURAL REBLEEDING AFTER IMPLANTATION OF LVIS BLUE FLOW DIVERTER (FD). UNKNOWN PATIENT INFORMATION. THE REBLEEDING RATE WAS 10% (N = 3), OCCURRING ON THE 1ST, 7TH, AND 13TH DAYS AFTER FD TREATMENT [REF. TABLE 3 OF ATTACHED ARTICLE]. TWO CASES INVOLVED THE USE OF PED FLEX + SHIELD FD, WHILE LVIS BLUE FD WITH ADDITIONAL COILING WAS USED IN ONE CASE. NOTABLY, TWO OF THE THREE ANEURYSMS THAT RE-BLED WERE LOCATED WITHIN THE POSTERIOR CIRCULATION, AND BOTH PATIENTS DIED DUE TO REBLEEDING. THE THIRD PATIENT WITH REBLEEDING FROM A POSTERIOR COMMUNICATING ARTERY ANEURYSM ACHIEVED A FAVORABLE OUTCOME (MRS 1) THAT WAS NEUROLOGICALLY STABLE AT THE LAST FOLLOW-UP. NO OTHER HEMORRHAGIC COMPLICATIONS WERE NOTED. IT IS UNKNOWN IF ANY OF THE PATIENTS WHO DIED HAD LVIS BLUE IMPLANTED. A RETROSPECTIVE REVIEW WAS PERFORMED OF ALL KNOWN PATIENTS TREATED WITH FDS FOR ASAH (WITHIN THE FIRST 15 DAYS AFTER SAH) AT OUR INSTITUTION BETWEEN JANUARY 2012 AND JANUARY 2024. VARIOUS COMMERCIALLY AVAILABLE FDS WERE USED, INCLUDING ALL THREE GENERATIONS OF PIPELINE EMBOLIZATION DEVICE (PED; MEDTRONIC, MINNEAPOLIS, MN), SURPASS STREAMLINE (STRYKER NEUROVASCULAR, FREMONT, CA), SURPASS EVOLVE (STRYKER NEUROVASCULAR, KALAMAZOO, ML), AND THE FLOW-REDIRECTION ENDOLUMINAL DEVICE X (FREDX; MICROVENTION, TUSTIN, CA). IN ADDITION, PATIENTS TREATED WITH THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT DEVICE (L VIS BLUE, MICROVENTION, TUSTIN, CA) WERE INCLUDED, AS IT DEMONSTRATES POROSITY AKIN TO APPROVED FDS AND GREATER THAN THAT OF CURRENTLY AVAILABLE INTRACRANIAL STENTS. BASED ON THE MORPHOLOGY AND CHARACTERISTICS OF THE ANEURYSM, THE PRIMARY PHYSICIAN WAS GIVEN THE DECISION REGARDING THE ADJUNCTIVE USE OF COILS WITH THE FD. IN AN ATTEMPT TO IMPROVE WALL APPOSITION, THE PHYSICIAN EMPLOYED BALLOON ANGIOPLASTY WHEN NEEDED. THE STUDY INCLUDED 30 PATIENTS, PREDOMINANTLY FEMALE, WITH A MEAN AGE OF 55.6 ± 14.4 YEARS (RANGE 30-87 YEARS). 6 PATIENTS IN THE STUDY HAD LVIS BLUE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035240 LVIS INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention