BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6074185 · Received November 2, 2016

    Report

    Report Number
    2029214-2016-00968
    Event Type
    Injury
    Date Received
    November 2, 2016
    Report Date
    October 5, 2016
    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

    ADDITIONAL INFORMATION: PLEASE REFERENCE MDR NUMBERS: 2029214-2016-00964, 2029214-2016-00965, AND 2029214-2016-00967 FOR THE OTHER MDRS SUBMITTED FROM THIS LITERATURE REVIEW.

    Additional Manufacturer Narrative · 1

    CITATION: C. LI · X. YANG · Y. LI · C. JIANG · Z. WU. ENDOVASCULAR TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS PRESENTING WITH INTRACRANIAL HEMORRHAGE IN 46 CONSECUTIVE PATIENTS: WITH EMPHASIS ON TRANSARTERIAL EMBOLIZATION WITH ONYX. CLIN NEURORADIOL (2016) 26:301¿308 DOI 10.1007/S00062-014-0362-Y. PUBLISHED ONLINE: 13 DECEMBER 2014. THERE IS LIMITED INFORMATION ABOUT THE DEVICES AND/OR THE PATIENTS, THEREFORE THE CAUSE OF THE DIFFICULTIES COULD NOT BE DETERMINED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICES WERE DEFECTIVE, BUT RATHER PROCEDURE RELATED EVENTS. ALL PATIENTS TREATED PRESENTED WITH INTRACRANIAL HEMORRHAGES. FUNCTIONAL NEUROLOGICAL DEFICITS SUCH AS CRANIAL NERVE PALSIES AND CARDIAC ARRHYTHMIAS, ARE KNOWN INHERENT RISKS OF ONYX PROCEDURE AND IS DOCUMENTED IN THE ONYX INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH A LITERATURE REVIEW THAT COMPLICATIONS OCCURRED DURING OR AFTER ENDOVASCULAR TREATMENT OF DURAL ARTERIOVENOUS FISTULAS (DAVFS) IN 11 CASES. IN ONCE CASE, DURING ONYX INJECTION, BRADYCARDIA CAUSED BY TRIGEMINOCARDIAC REFLEX (TCR) OCCURRED, WHICH WAS EFFECTIVELY EXTINGUISHED AFTER ADMINISTERING ATROPINE. IN 2 CASES, FACIAL NERVE PARESIS OCCURRED AND OCULOMOTOR NERVE PARESIS IN ONE. ONE PATIENT PRESENTING WITH FACIAL NERVE PARESIS STILL SUFFERED FROM SLIGHT FACIAL NERVE PARESIS AT THE 22 MONTH FOLLOW UP. THE 2 OTHER PATIENTS WITH CRANIAL NERVE PARESIS RECOVERED WELL DURING THE FOLLOW-UP PERIOD WITHOUT SYMPTOM AT CLINICAL FOLLOW UP. IN THE 3 CASES OF NERVE PARESE IT IS NOT CLEAR THEY OCCURRED AFTER USE OF NBCA OR WITH THE ONYX. 7 PATIENTS UNDERWENT GAMMA KNIFE TREATMENT AS A SUPPLEMENTARY TREATMENT AFTER THE DAVF PROCEDURE. ANGIOGRAPHIC FOLLOW-UP RESULTS WAS AVAILABLE IN 4 OF THE SEVEN PATIENTS ACCEPTING SUPPLEMENTARY GAMMA KNIFE SURGERY. TWO NEAR-TOTALLY OBLITERATED FISTULAS WERE TRANSFORMED INTO TOTALLY OBLITERATED, ANOTHER NEAR-TOTALLY OBLITERATED FISTULA WAS STILL NEARLY TOTALLY OBLITERATED, BUT SUPPRESSION OF CVR WAS OBSERVED COMPARED WITH IMMEDIATE ANGIOGRAPHIC OUTCOMES AFTER EVT, AND 1 PARTIALLY OBLITERATED FISTULA WAS TRANSFORMED INTO NEAR-TOTALLY OBLITERATED. THE ARTICLE DID NOT SPECIFY IF THESE PATIENTS UNDERWENT ONYX EMBOLIZATION OR NBCA. THE PURPOSE OF THE STUDY DISCUSSED IN THE ARTICLE WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY AS WELL AS THE CLINICAL AND ANGIOGRAPHIC RESULTS OF THE ENDOVASCULAR TREATMENT (EVT) FOR PATIENTS WITH HEMORRHAGIC DURAL ARTERIOBENOUS FISTULAS (DAVFS). FROM 2009 TO NOVEMBER 2014, 46 CONSECUTIVE PATIENTS WITH HEMORRHAGIC INTRACRANIAL DAVFS WERE ENROLLED. THE CLINICAL AND ANGIOGRAPHIC DATA WERE REVIEWED AND EVALUATED. IN THIS RETROSPECTIVE STUDY, ANGIOGRAPHIC AND CLINICAL OUTCOMES OF THE 46 PATIENTS WITH HEMORRHAGIC DAVFS TREATED WITH EVT WAS REVIEWED. THE AUTHORS CONCLUDED THAT EVT WAS EFFECTIVE AND SAFE IN THE MODERN MANAGEMENT OF RUPTURED INTRACRANIAL DAVFS, WITH COMPLETE CURE IN MOST LESIONS. CLINICAL OUTCOMES WERE GOOD DESPITE PATIENTS PRESENTING WITH INTRACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723411 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other