BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX ANEURYSM

    MDR report key: 4642599 · Received March 30, 2015

    Report

    Report Number
    2029214-2015-00315
    Event Type
    Injury
    Date Received
    March 30, 2015
    Date of Event
    May 20, 2005
    Report Date
    March 5, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OBA
    PMA / PMN Number
    H060003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-005-0007-6. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENTS. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. NERVE DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL. PROCODE: OBA. PMA H060003. REFERENCE (B)(4).

    Description of Event or Problem · 1

    CITATION: H. SARUHAN CEKIRGE ET AL. LATE ANGIOGRAPHIC AND CLINICAL FOLLOW-UP RESULTS OF 100 CONSECUTIVE ANEURYSMS TREATED WITH ONYX RECONTRUCTION: LARGES SINGLE CENTER EXPERIENCE. NEURORADIOLOGY (2006) 48: MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THROUGH LITERATURE REVIEW AND THE FOLLOWING EVENT(S) WERE CAPTURED AS A RESULT OF THE REVIEW: A TOTAL OF 100 ANEURYSMS IN 94 PATIENTS WERE TREATED WITH ENDOVASCULAR ONYX PACKING. INTRACRANIAL STENTING WAS USED ADJUNCTIVELY IN 25 ANEURYSMS INCLUDING 19 DURING INITIAL TREATMENT AND 6 DURING RETREATMENT. THE PATIENT¿S AGE RANGED BETWEEN 6 AND 71 YEARS WITH A MEAN OF 41 YEARS. ALL OF THE ANEURYSMS WERE LOCATED AT THE INTERNAL CAROTID ARTERY EXCEPT IN ONE PATIENT WHO HAD A BASILAR TIP AND SUPERIOR CEREBELLAR ARTERY ANEURYSMS. COMPLETE OCCLUSION WAS ACHIEVED IN 90 OUT OF 100 ANEURYSMS TREATED. PROCEDURE /DEVICE RELATED ADVERSE EVENTS RESULTED IN PERMANENT NEUROLOGICAL DEFICIT IN EIGHT PATIENTS. AMONG THESE, TWO PATIENTS RESULTED IN DEPENDENT SURVIVAL (MRS 4), ONE HAVING TOTAL OPTHALMOPLEGIA AND THE OTHER DEVELOPED RIGHT MIDDLE CEREBRAL ARTERY INFARCT 3 DAYS AFTER TREATMENT; CAUSED LEFT ARM AFTER STENT/ONYX TREATMENT. THE REMAINING SIX TRANSIENT NEUROLOGICAL ADVERSE EVENTS (6.4%) RESOLVED COMPLETELY. AS FOR CRANIAL NERVE PALSIES, 15 PATIENTS PRESENTED WITH OCULOMOTOR PALSIES. IN 11 OF THESE THE CONDITION HAD COMPLETELY RESOLVED AND 2 SHOWED IMPROVEMENT AT THE 12 MONTH FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208546 ONYX ANEURYSM POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL OBA COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability