BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 12571640 · Received October 4, 2021

    Report

    Report Number
    1226348-2021-00076
    Event Type
    Death
    Date Received
    October 4, 2021
    Date of Event
    November 1, 2019
    Report Date
    September 7, 2021
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). LITERATURE ARTICLE ¿MULTIMODAL CEREBRAL ARTERIOVENOUS MALFORMATION TREATMENT: A 12-YEAR EXPERIENCE AND COMPARISON OF KEY OUTCOMES TO ARUBA¿ REVIEWED. PULLI B, CHAPMAN PH, OGILVY CS, PATEL AB, STAPLETON CJ, LESLIE-MAZWI TM, HIRSCH JA, CARTER BS, RABINOV JD. J NEUROSURG. 2019 NOV 1:1-10. DOI: 10.3171/2019.8.JNS19998. EPUB AHEAD OF PRINT. PMID: 31675689. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ¿MULTIMODAL CEREBRAL ARTERIOVENOUS MALFORMATION TREATMENT: A 12-YEAR EXPERIENCE AND COMPARISON OF KEY OUTCOMES TO ARUBA¿ REVIEWED. PULLI B, CHAPMAN PH, OGILVY CS, PATEL AB, STAPLETON CJ, LESLIE-MAZWI TM, HIRSCH JA, CARTER BS, RABINOV JD. J NEUROSURG. 2019 NOV 1:1-10. DOI: 10.3171/2019.8.JNS19998. EPUB AHEAD OF PRINT. PMID: 31675689. OBJECTIVE: CURATIVE TREATMENT OF UNRUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS) REMAINS CONTROVERSIAL AFTER THE ONLY RANDOMIZED CONTROLLED TRIAL, A RANDOMIZED TRIAL OF UNRUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS (ARUBA), WAS HALTED PREMATURELY BECAUSE INTERIM ANALYSIS REVEALED SUPERIORITY OF THE MEDICAL MANAGEMENT GROUP. IN CONTRAST, META-ANALYSES OF RETROSPECTIVE COHORTS SUGGEST THAT INTERVENTION IS MUCH SAFER THAN WAS FOUND IN ARUBA. METHODS THE AUTHORS RETROSPECTIVELY ANALYZED 318 CONSECUTIVE ADULT PATIENTS WITH BRAIN AVMS TREATED AT THEIR INSTITUTION WITH EMBOLIZATION, SURGERY, AND/OR PROTON BEAM RADIOSURGERY. ANALYSIS WAS PERFORMED IN 142 ARUBA-ELIGIBLE PATIENTS (BASELINE MODIFIED RANKIN SCALE [MRS] SCORE 0¿1, NO HISTORY OF HEMORRHAGE), AND RESULTS WERE COMPARED TO PRIMARY AND SECONDARY OUTCOMES FROM ARUBA, AS WELL AS TO NATURAL HISTORY COHORTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRUFILL N-BUTYL CYANOACRYLATE (CODMAN) OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: ONYX (MEDTRONIC), STEREOTACTIC BRAGG PEAK, PROTON BEAM THERAPY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: INTRAPROCEDURAL CAVM RUPTURE. POSTOPERATIVE HEMORRHAGE REQUIRING REPEAT CRANIOTOMY AND HEMATOMA EVACUATION. STROKE (EITHER ISCHEMIC OR HEMORRHAGIC). DEATH WAS ATTRIBUTED TO EMBOLIZATION (INTRAPROCEDURAL AVM RUPTURE THAT REQUIRED EMERGENCY CRANIOTOMY FOR CLOT EVACUATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469069 UNK LIQUID EMBOLIC LIQUID EMBOLIC KGG CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ONYX MEDTRONIC| STEREOTACTIC BRAGG PEAK, PROTON BEAM THERAPY