BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX LES

    MDR report key: 6517081 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00500
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    October 28, 2010
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: MDRS FROM THIS EVENT: 2029214-2017-00499, 2029214-2017-00500 MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00501, 2029214-2017-00502, AND 2029214-2017-00503.

    Additional Manufacturer Narrative · 1

    CITATION: FENG XU, WEI NI, YUJUN LIAO, YUXIANG GU, BIN XU, BING LENG, DONGLEI SONG. ONYX EMBOLIZATION FOR THE TREATMENT OF BRAIN A RTERIOVENOUS MALFORMATIONS. ACTA NEUROCHIR (2011). PUBLISHED ONLINE: 28 OCTOBER 2010 THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EXPERIENCE IN THE TREATMENT OF BRAIN AVMS WITH ONYX EMBOLIZATION. BETWEEN JANUARY 2004 AND DECEMBER 2007, 86 PATIENTS WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THE AUTHORS CONCLUDE THAT ALTHOUGH ONYX ALLOWS MODERATE OBLITERATION RATES, COMBINED MANAGEMENT, SUCH AS ADJUNCTIVE EMBOLIZATION WITH MICROSURGERY OR RADIOSURGERY, MAY BE EFFECTIVE FOR SELECTED LARGE AVMS. THE MEAN PATIENT AGE WAS 30.3 YEARS (RANGE, 8¿55 YEARS). THERE WERE 51 MEN AND 35 WOMEN. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THIS WAS AN EVENT CAPTURED THROUGH LITERATURE REVIEW. THERE IS LIMITED PATIENT AND DEVICE INFORMATION AVAILABLE; IN THIS ARTICLE IT WAS REPORTED THAT BOTH THE MARATHON AND ULTRAFLOW MICROCATHETERS WERE USED. HOWEVER, IT WAS NOT REPORTED WHICH MICROCATHETER WAS USED IN THIS PROCEDURE. ADDITIONALLY, THE AMOUNT OF ONYX REFLUX/ENTRAPMENT WAS NOT CAPTURED IN THE ARTICLE. BASED ON THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON EACH CASE; SHOULD THE INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-00499, 2029214-2017-00500 MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00501.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT IN 1 PATIENT, ARTERIAL PERFORATION OCCURRED WITH CATHETER (MARATHON OR ULTRAFLOW) MANIPULATION WAS SEALED(ENTRAPPED) WITH GLUE/ONYX. THE PATIENT TOLERATED THE PERFORATION WITHOUT NEUROLOGIC DEFICIT. THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EXPERIENCE IN THE TREATMENT OF BRAIN AVMS WITH ONYX EMBOLIZATION. BETWEEN JANUARY 2004 AND DECEMBER 2007, 86 PATIENTS WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. CLINICAL PRESENTATION INCLUDED INTRACEREBRAL HEMORRHAGE IN 32 PATIENTS, SEIZURES IN 25 PATIENTS, HEADACHES IN 20 PATIENTS, NEUROLOGIC DEFICITS IN 3 PATIENTS, AND IN 6 PATIENTS THE AVM WAS AN INCIDENTAL FINDING. EMBOLIZATION-RELATED PERMANENT MORBIDITY WAS 3.5%, WHEREAS MORTALITY WAS 1.2%. THE AUTHORS CONCLUDE THAT ALTHOUGH ONYX ALLOWS MODERATE OBLITERATION RATES, COMBINED MANAGEMENT, SUCH AS ADJUNCTIVE EMBOLIZATION WITH MICROSURGERY OR RADIOSURGERY, MAY BE EFFECTIVE FOR SELECTED LARGE AVMS. THE MEAN PATIENT AGE WAS 30.3 YEARS (RANGE, 8¿55 YEARS). THERE WERE 51 MEN AND 35 WOMEN. ACCORDING TO THE SPETZLER¿MARTIN GRADING SCALE [35], 3 AVMS (3.5%, 3/86) WERE GRADE I, 13 (15.1%, 13/86) WERE GRADE II, 45 (52.3%, 45/86) WERE GRADE III, 19 (22.1%, 19/86) WERE GRADE IV, AND 6 (7.0%, 6/86) WERE GRADE V (TABLE 3). A TOTAL OF 74 (86%) OF THE AVMS WERE LOCATED IN ELOQUENT REGIONS. STAGED SESSIONS OF EMBOLIZATION WERE PLANNED FOR PARTIALLY OCCLUDED AVMS. CITATION: FENG XU, WEI NI, YUJUN LIAO, YUXIANG GU, BIN XU, BING LENG, DONGLEI SONG. ONYX EMBOLIZATION FOR THE TREATMENT OF BRAIN A RTERIOVENOUS MALFORMATIONS. RECEIVED: 9 AUGUST 2010 / ACCEPTED: 14 OCTOBER 2010 / PUBLISHED ONLINE: 28 OCTOBER 2010 ACTA NEUROCHIR (2011) PES FROM THIS LITERATURE REVIEW: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298097 ONYX LES AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other