BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 17637656 · Received August 28, 2023

    Report

    Report Number
    2029214-2023-01507
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    January 11, 2021
    Report Date
    August 28, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. NO SPECIFIC DEVICE INFORMATION RECEIVED. SEE ATTACHED LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CHUA, M. M. J., GUPTA, S., ESSAYED, W. I., DONNELLY, D. J., ZIAYEE, H., VICENTY-PADILLA, J., DAS, A. S., LAI, P. M., IZZY, S., AZIZ-SULTAN, M. A. ENDOVASCULAR TREATMENT OF A RUPTURED POSTERIOR FOSSA PURE ARTERIAL MALFORMATION: ILLUSTRATIVE CASE. J NEUROSURG CASE LESSONS. 1(2):(B)(4). 2021. DOI: 10.3171/(B)(4). SUMMARY: D PURE ARTERIAL MALFORMATIONS (PAMS) ARE RARE VASCULAR ANOMALIES THAT ARE COMMONLY MISTAKEN FOR OTHER VASCULAR MALFORMATIONS. BECAUSE OF THEIR PURPORTED BENIGN NATURAL HISTORY, PAMS ARE OFTEN CONSERVATIVELY MANAGED. THE AUTHORS REPORT THE CASE OF A RUPTURED PAM LEADING TO SUBARACHNOID HEMORRHAGE (SAH) WITH INTRAVENTRICULAR EXTENSION THAT WAS TREATED ENDOVASCULARLY. A 38-YEAR-OLD MAN PRESENTED WITH A 1-DAY HISTORY OF HEADACHES AND NAUSEA. A COMPUTED TOMOGRAPHY SCAN DEMONSTRATED DIFFUSE SAH WITH INTRAVENTRICULAR EXTENSION, AND ANGIOGRAPHY REVEALED A RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY¿ASSOCIATED PAM. THE PAM WAS TREATED WITH ENDOVASCULAR ONYX EMBOLIZATION. TO THE AUTHORS¿ KNOWLEDGE, ONLY 2 OTHER CASES OF SAH ASSOCIATED WITH PAM HAVE BEEN REPORTED. IN THOSE 2 CASES, SURGICAL CLIPPING WAS PURSUED FOR DEFINITIVE TREATMENT. HERE, THE AUTHORS REPORT THE FIRST CASE OF A RUPTURED PAM TREATED USING AN ENDOVASCULAR APPROACH, SHOWING ITS FEASIBILITY AS A TREATMENT OPTION PARTICULARLY IN PATIENTS IN WHOM OPEN SURGERY IS TOO HIGH A RISK. REPORTED EVENTS: POSTOPERATIVELY, THE PATIENT WAS TRANSFERRED BACK TO THE ICU IN STABLE CONDITION. HE WAS FOUND TO HAVE BILATERAL LOWER EXTREMITY WEAKNESS, WITH ABNORMAL T2 PROLONGATION AT THE DORSAL CERVICOMEDULLARY JUNCTION AND UPPER CERVICAL CORD VISUALIZED BY MAGNETIC RESONANCE IMAGING (MRI), CONCERNING FOR A SUBACUTE STROKE(FIG. 5). THIS MAY HAVE OCCURRED BECAUSE OF ONYX PROPAGATION TO A LATERAL MEDULLARY ARTERY ARISING FROM THE RIGHT PICA THAT WAS NOT OBSERVED ON THE CTA SCAN OR THE ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339894 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown