BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 7026150 · Received November 13, 2017

    Report

    Report Number
    2029214-2017-01246
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    May 1, 2015
    Report Date
    November 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IOSIF, C. ET AL. (2015). ENDOVASCULAR TRANSVENOUS CURE FOR RUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS IN COMPLEX CASES WITH HIGH SPE TZLER-MARTIN GRADES. JOURNAL OF NEUROSURGERY, 122, 1229-1238. DOI:10.3171/2014.9.JNS141714 THE ONYX-18 WAS CONSUMED DURING THE PROCEDURES AND REMAINS IN THE PATIENTS; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE ONYX DURING USE. THE CAUSE OF THE EVENTS CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF COMPLICATIONS DURING OR AFTER ONYX-18 EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO REPORT THE EXPERIENCE WITH CURATIVE ENDOVASCULAR TRANSVENOUS EMBOLIZATION IN A SERIES OF PATIENTS WITH ¿UNTREATABLE¿ LESIONS. THE AUTHORS REVIEWED 20 PATIENTS (10 MALE, 10 FEMALE, MEAN AGE 36.7 YEARS) WITH RUPTURED CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WITH DEEP LOCALIZATION AND HIGH SPETZLER-MARTIN GRADES WHO UNDERWENT TREATMENT USING TRANSVENOUS EMBOLIZATION PROTOCOL. DURING THE PROCEDURES, ONYX 18 WAS USED AS THE EMBOLIC AGENT. THE ARTICLE STATES THAT THE FOLLOWING COMPLICATIONS OCCURRED: - CASE 13 ((B)(6), MALE) EXPERIENCED INTRAPROCEDURAL VENOUS RUPTURE. THE PROCEDURE WAS CONTINUED UNTIL COMPLETE OCCLUSION OF THE NIDUS WAS ACHIEVED WITHOUT CLINICALLY EVIDENT CONSEQUENCES - CASE 5 ((B)(6), FEMALE) EXPERIENCED INTRAPROCEDURAL ARTERIAL PEDICLE DISSECTION THAT WAS MANAGED WITHOUT CLINICAL CONSEQUENCE. IN THIS CASE, TRANSVENOUS INJECTION ALLOWED FOR A COMPLETE ERADICATION OF THE NIDUS. - CASE 20 ((B)(6), MALE) EXPERIENCED POST-OPERATIVE HEMORRHAGIC TRANSFORMATION. THE PATIENT UNDERWENT ONYX EMBOLIZATION OF A CORTICAL AND WHITE MATTER RIGHT PARIETAL AVM WITH SINGLE CORTICAL VENOUS DRAINAGE TO THE SUPERIOR SAGITTAL SINUS. WITHIN 24 HOURS OF EMBOLIZATION, THE PATIENT DEVELOPED MRI-CONFIRMED HEMORRHAGIC TRANSFORMATION OF A VENOUS INFARCTION SURROUNDING THE NIDUS. AT DISCHARGE THE PATIENT HAD AN MRS OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805651 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other