BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6574457 · Received May 17, 2017

    Report

    Report Number
    2029214-2017-00663
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 25, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WOJCIECH PONCYLJUSZ, MARCIN SAWICKI, KATARZYNA LUBKOWSKA, MONIKA RAC. EARLY OUTCOMES AND PERIPROCEDURAL COMPLICATIONS OF T RANSARTERIAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS WITH ONYX. POLISH NEUROLOGICAL SOCIETY. 2017. ACCEPTED 23 MARCH 2017. THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF ENDOVASCULAR TREATMENT OF BAVM WITH ONYX BY REPORTING ONE-CENTER EXPER IENCE. BETWEEN 2006 AND 2013, 54 PATIENTS WITH BAVM WERE EMBOLIZED WITH ONYX. 108 PROCEDURES WERE PERFORMED. THE GROUP CONSISTED OF 24 MALES AND 30 FEMALES, AGED 10 TO 65 YEARS (MEAN 42.6+/- 15.4). CLINICAL MANIFESTATIONS OF BAVMS WERE: HEMORRHAGE IN 27 (50.0%), HEADACHES IN 12 (22.2%), SEIZURES IN 7 (13.0%) AND FOCAL NEUROLOGIC DEFICITS IN 2 (3.7%) PATIENTS. SIX (11.1%) PATIENTS WERE ASYMPTOMATIC. A MAJORITY OF BAVMS WERE OF II AND III GRADE IN SPETZLER-MARTIN SCALE (19 AND 22 CASES RESPECTIVELY). THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE THE EVENT CAUSE COULD NOT BE RELIABLY DETERMINED. FOR THE 4 CASES HEMORRHAGIC COMPLICATIONS IT WAS REPORTED THAT VENOUS CONGESTION WAS OBSERVED BEFORE THE NIDUS WAS COMPLETELY OCCLUDED. THE CAUSES OF HEMORRHAGIC COMPLICATIONS WAS DUE TO HEMODYNAMIC CHANGES IN THE NIDUS CAUSED BY PASSAGE OF EMBOLIC AGENT TO THE VENOUS SIDE OF MALFORMATION (VENOUS STAGNATION). HEMODYNAMIC CHANGES INDUCED BY THE EMBOLIZATION THAT MAY RESULT IN HEMORRHAGIC COMPLICATIONS ARE KNOWN INHERENT RISKS OF THE ONYX EMBOLIZATION PROCEDURE AND ARE DOCUMENTED IN THE INSTRUCTIONS FOR USE. FOR THE CATHETER ENTRAPMENT, IT IS POSSIBLE THAT THERE MIGHT HAVE BEEN SIGNIFICANT REFLUX WHICH MAY LED TO THE REPORTED ISSUE. PER OUR INSTRUCTIONS FOR USE (IFU): ¿DIFFICULT CATHETER REMOVAL OR CATHETER ENTRAPMENT MAY BE CAUSED BY ONE OR MORE OF THE FOLLOWING FACTORS: LONG CATHETERIZATION TIME; ANGIO-ARCHITECTURE (VERY DISTAL ARTERIOVENOUS MALFORMATION FED BY AFFERENT, LENGTHENED, SMALL, OR TORTUOUS PEDICLES); VASOSPASM; REFLUX; INJECTION TIME. TO REDUCE THE RISK OF CATHETER ENTRAPMENT, CAREFULLY SELECT CATHETER PLACEMENT AND MANAGE REFLUX TO MINIMIZE THE FACTORS LISTED ABOVE." BASED ON THE REPORTED INFORMATION, REVIEW OF THE IFU, AND REVIEW OF THE LITERATURE TO INVESTIGATE THIS EVENT, THE MOST LIKELY CAUSE OF THE REPORTED EVENTS IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORRESPONDING AUTHOR, HOWEVER NO INFORMATION HAS BEEN PROVIDE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00661, 2029214-2017-00662 2029214-2017-00663, 2029214-2017-00664.

    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 NON-FATAL COMPLICATIONS OCCURRED IN 5 OUT OF 108 ONYX EMBOLIZATION PROCEDURES PERFORMED ON 54 PATIENTS. ONE WAS ISCHEMIC RESULTING FROM ENTRAPMENT OF THE MARATHON MICRO CATHETER, AND 4 WERE HEMORRHAGIC (INTRACEREBRAL HEMATOMAS). THE PATIENTS WERE RECEIVING ONYX EMBOLIZATION PROCEDURE TO TREAT BRAIN ARTERIOVENOUS MALFORMATIONS (BAVM). PROCEDURAL COMPLICATIONS OF EMBOLIZATION WERE NOTED DURING ONE-MONTH FOLLOW-UP PERIOD AFTER THE LAST SESSION. FOR THE ISCHEMIC COMPLICATION, THE STROKE OCCURRED IN THE SPETZLER-MARTIN II PLEXIFORM BAVM WITH STENOTIC DRAINING VEINS. IN THIS CASE, THE MARATHON MICRO CATHETER WAS TRAPPED IN THE SINGLE FEEDER (PCA) AND RUPTURED DURING FORCEFUL RETRIEVAL. THE RESULTING SYMPTOMS WERE ATAXIA AND VERTIGO. MOTOR AND NEUROPSYCHOLOGICAL REHABILITATION RESULTED IN PARTIAL REGRESSION OF SYMPTOMS. IN THE REMAINING 4 CASES WITH INTRACEREBRAL BLEEDINGS, VENOUS CONGESTION WAS OBSERVED BEFORE THE NIDUS WAS COMPLETELY OCCLUDED. THE COMPLICATIONS RESULTED IN PERMANENT DEFICITS IN TWO PATIENTS. THE DEFICITS FOR ONE PATIENT WERE TRANSIENT DIPLOPIA AND UNILATERAL DEAFNESS, WHICH WAS PERMANENT AND REPORTEDLY NOT RELATED TO EMBOLIZATION. THE DEFICITS FOR THE OTHER PATIENT WAS DISTURBANCE OF CONSCIOUSNESS, PSYCHOMOTOR HYPERACTIVITY, RIGHT SIDED HEMIPARESIS, WHICH REMAINS. THE OTHER 2 PATIENTS BOTH HAD RIGHT SIDED HEMIPARESIS WHICH WAS CONSIDERED TRANSITORY AFTER CRANIECTOMY WITH HEMATOMA EVACUATION AND PLACEMENT OF AN EVD RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352717 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability