BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COIL-HYDRAULIC

    MDR report key: 12573218 · Received October 4, 2021

    Report

    Report Number
    3008114965-2021-00493
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    July 12, 2019
    Report Date
    September 7, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K123560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). LITERATURE ARTICLE ¿CURATIVE TREATMENT FOR LOW-GRADE ARTERIOVENOUS MALFORMATIONS¿ REVIEWED. WANG A, MANDIGO GK, FELDSTEIN NA, SISTI MB, CONNOLLY ES, SOLOMON RA, LAVINE SD, MEYERS PM. J NEUROINTERV SURG. 2020 JAN;12(1):48-54. DOI: 10.1136/NEURINTSURG-2019-015115. EPUB 2019 JUL 12. PMID: 31300533. 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 · 0

    LITERATURE ARTICLE ¿CURATIVE TREATMENT FOR LOW-GRADE ARTERIOVENOUS MALFORMATIONS¿ REVIEWED. WANG A, MANDIGO GK, FELDSTEIN NA, SISTI MB, CONNOLLY ES, SOLOMON RA, LAVINE SD, MEYERS PM. J NEUROINTERV SURG. 2020 JAN;12(1):48-54. DOI: 10.1136/NEURINTSURG-2019-015115. EPUB 2019 JUL 12. PMID: 31300533. OBJECTIVE: TO ASSESS THE SAFETY OF COMBINED TREATMENT OF GRADE I-­II AVMS WITH PREOPERATIVE EMBOLIZATION FOLLOWED BY SURGICAL RESECTION OR RADIOSURGERY AND DETERMINE THE LONG-TERM FUNCTIONAL OUTCOMES. METHODS: WITH INSTITUTIONAL REVIEW BOARD APPROVAL, A RETROSPECTIVE ANALYSIS WAS CARRIED OUT ON PATIENTS WITH RUPTURED AND UNRUPTURED SM I-­II AVMS BETWEEN 2002 AND 2017. DETAILS OF THE ENDOVASCULAR PROCEDURES, INCLUDING NUMBER OF ARTERIES SUPPLYING THE AVM, NUMBER OF BRANCHES EMBOLIZED, EMBOLIC AGENT(S) USED, AND COMPLICATIONS WERE STUDIED. BASELINE CLINICAL AND IMAGING CHARACTERISTICS WERE COMPARED. FUNCTIONAL STATUS USING THE MODIFIED RANKIN SCALE (MRS) BEFORE AND AFTER ENDOVASCULAR AND MICROSURGICAL TREATMENTS WAS COMPARED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRUFILL N-BUTYL CYANOACRYLATE, CORDIS AND DETACHABLE COILS, POLYVINYL ALCOHOL TRUFILL PVA, CORDIS OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: ETHYLENE VINYL COPOLYMER ONYX, MEDTRONIC DETACHABLE COILS, POLYVINYL ALCOHOL PVA, CONTOUR, STRYKER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (2) POSTPROCEDURAL HEMORRHAGES, 1 RESULTING IN A SMALL ASYMPTOMATIC SUBARACHNOID HEMORRHAGE AND 1 IN A LARGE CEREBELLAR HEMATOMA REQUIRING EMERGENCY EVACUATION. (1) POSTPROCEDURAL INFARCT OF THE OCCIPITAL LOBE IN A PATIENT WITH AN OCCIPITAL POLE AVM AFTER EMBOLIZATION OF THE POSTERIOR CEREBRAL ARTERY BRANCH TO THE AVM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469825 UNK COIL-HYDRAULIC COIL-HYDRAULIC HCG MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening