BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20649027 · Received November 10, 2024

    Report

    Report Number
    2029214-2024-02106
    Event Type
    Injury
    Date Received
    November 10, 2024
    Date of Event
    August 9, 2022
    Report Date
    November 10, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: SANCHEZ, M. E., LAWTON, M. T., & ABLA, A. A. NATURAL HISTORY, ANGIOGRAPHIC PRESENTATION, AND OUTCOMES OF ANTERIOR CRANIAL FOSSA DURAL ARTERIOVENOUS FISTULAS. JOURNAL OF NEUROSURGERY 136(4), 902-911 2022. 10.3171/2021.5.JNS21217. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    THE STUDY TITLED "NATURAL HISTORY, ANGIOGRAPHIC PRESENTATION, AND OUTCOMES OF ANTERIOR CRANIAL FOSSA DURAL ARTERIOVENOUS FISTULAS (A CF-DAVFS)" WAS REVIEWED. THE STUDY TIMEFRAME RANGED FROM 1990 TO 2017. THE MEDTRONIC DEVICE USED WAS ONYX. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED HEMORRHAGE, NON-HEMORRHAGIC NEUROLOGICAL DEFICITS, VENOUS HYPERDYNAMIC SYMPTOMS, ARTERIAL FEEDERS, SINUS/VENOUS DRAINAGE, AND TREATMENT OUTCOMES SUCH AS MICROSURGERY AND ENDOVASCULAR EMBOLIZATION. THE STUDY CONCLUDED THAT MOST ACF-DAVFS PRESENTED WITH INTRACRANIAL HEMORRHAGE AND THAT MICROSURGERY WAS MORE EFFECTIVE THAN ENDOVASCULAR THERAPY AND RADIOSURGERY IN ACHIEVING COMPLETE FISTULA CLOSURE. THE DETAILED ANALYSIS OF THE ANGIOARCHITECTURE WAS ALSO EMPHASIZED AS CRUCIAL IN DECIDING THE BEST TREATMENT CHOICE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS BASED ON THE ADDITIONAL CONTEXT PROVIDED. COMPLETE OBLITERATION OF THE ACF-DAVF WAS ACHIEVED IN 53% (9/17) OF PATIENTS WHO UNDERWENT ENDOVASCULAR SURGERY. OF THESE CASES, 67% (6/9) ACHIEVED ACF-DAVF CLOSURE WITH ONE INTERVENTION AND 33% (3/9) REQUIRED A SECOND INTERVENTION. ENDOVASCULAR THERAPY WAS NOT EFFECTIVE IN 47% (8/17) OF PATIENTS. CAUSES FOR FAILURE WERE PERSISTENT VENOUS DRAINAGE (62%, 5/8) OR THE INABILITY TO ACCESS THE TARGET ARTERIAL FEEDER (38%, 3/8). TRANSIENT NEUROLOGICAL COMPLICATIONS OCCURRED IN TWO PATIENTS (12%, 2/17): PARTIAL OCCLUSION OF THE OPHTHALMIC ARTERY WITH NO PERMANENT NEUROLOGICAL DEFICIT, AND A PARTIAL TRANSIENT CRANIAL NERVE III PALSY. OF THE EIGHT PATIENTS IN WHOM ENDOVASCULAR THERAPY WAS NOT SUCCESSFUL, 63% (5/8) UNDERWENT MICROSURGERY, 12% RADIOSURGERY (1/8) AND 25% (2/8) DID NOT PURSUE ADDITIONAL TREATMENT. ALL PATIENTS WHO UNDERWENT MICROSURGERY AFTER A FAILED ENDOVASCULAR THERAPY ACHIEVED CURE. RADIOSURGERY WAS NOT EFFECTIVE AS BOTH PRIMARY OR SECONDARY TREATMENTS. IN THE ENDOVASCULAR GROUP, 64% (11/17) OF PATIENTS UNDERWENT ENDOVASCULAR INTERVENTION AS THE PRIMARY TREATMENT. THE REST (36%, 6/17) OF PATIENTS IN WHOM ENDOVASCULAR THERAPY WAS ATTEMPTED WERE TREATED WITH MULTIMODAL TREATMENT AFTER UNSUCCESSFUL ENDOVASCULAR INTERVENTION. OF THE SEVEN SYMPTOMATIC PATIENTS WHO UNDERWENT ENDOVASCULAR THERAPY AS A PRIMARY TREATMENT, 14% (1/7) REMAINED STABLE, 43% (3/7) HAD COMPLETE RESOLUTION OF SYMPTOMS AND 43% (3/7) HAD WORSENING OF SYMPTOMS. ONE PATIENT HAD NEW INTRACEREBRAL HEMORRHAGE 56 DAYS AFTER ACF-DAVF CLOSURE. THIS PATIENT HAD A FAILED FIRST TRANSARTERIAL ENDOVASCULAR PROCEDURE, BUT ACHIEVED SUCCESSFUL ACF-DAVF CLOSURE IN THE SECOND TRANSARTERIAL ENDOVASCULAR PROCEDURE. EIGHTEEN PERCENT (2/11) HAD ANGIOGRAPHIC RECURRENCE OF THE ACF-DAVF AT AN AVERAGE OF 75 DAYS POST-TREATMENT. SIXTY-SEVEN PERCENT (4/6) OF PATIENTS WITH MULTIMODAL THERAPY AFTER FAILED ENDOVASCULAR SURGERY WERE SYMPTOMATIC AT ONSET. ALL OF THESE PATIENTS (4/4) HAD RESOLUTION OF SYMPTOMS AT FOLLOW-UP. THE PATIENT IN WHOM RADIOSURGERY FAILED AS A PRIMARY TREATMENT HAD STABLE SYMPTOMS AT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317503 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention