MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

Patient Problems Fistula (1862); Hearing Impairment (1881); Hematoma (1884); Rupture (2208)

Event Date 02/07/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Noriaki tashiro, hiroto kawano, fumihiro hiraoka, yusuke nakamura, shuji fukuda, shigetoshi yano, hiroshi aikawa, yoshinori go, kiyoshi kazekawa, yoshihisa matsumoto (2021)iatrogenic middle meningeal arteriovenous fistula during embolization: two case reports and literature review.Journal of stroke and cerebrovascular diseases 30(8) medtronic literature review found report of defrictor microcatheter from another manufacturer was partially trapped by an onyx 18.  the purpose of the article was to identify cases of iatrogenic middle meningeal arteriovenous fistula due to vascular injury sustained during endovascular treatment.The patient was a (b)(6) year old female. present illness: an internal carotid artery aneurysm was identified and she selected endovascular treatment.During the endovascular procedure, a davf was discovered in the cerebellar tentorium incidentally.The patient was admitted to institution for treatment.The petrosquamous branch of the middle meningeal artery (mma) was selected as the target vessel; however, the tortuosity of the artery required using a catheter from another manufacturer as a distal access catheter (dac). a defrictor microcatheter was navigated to the petrosquamous branch of the mma with a guidewire from another manufacturer through the dac.Transarterial embolization was performed using onyx 18, which flowed into the shunt point from the petrosquamous branch of the mma as well as retrograde into the oa, one of the feeding vessels. when we removed the defrictor, the dac was forced to move distally beyond the foramen spinosum along the mma to the pterional segment as the dac was not trapped by the onyx but the defrictor was partially trapped by the onyx.A middle meningeal arteriovenous fistula (mmavf) was identified near the distal tip of the relocated the dac.As we could not find the mmavf before removing the defrictor, it appeared that the mma had ruptured when the dac was forced to move distally. cone beam computed tomography (ct) scans were immediately performed, and the absence of lesions such as epidural or subdural hematoma was confirmed.The procedure was ended with the expectation that the fistula would spontaneously resolve. after the procedure, the patient became aware of pulsatile tinnitus in her left ear.Irregular hyperintensity around the left mma was observed on cranial magnetic resonance angiography (mra).On postoperative day 3, it was decided to treat the mmavf to improve her tinnitus symptoms. endovascular procedure (second time): a guiding catheter from another manufacturer was placed at the left eca.The position of the mmavf was defined by angiography.Since liquid embolic agents carry a risk of cranial nerve palsy, it was decided to occlude the fistula using a coil.An echelon 10 microcatheter for coiling was navigated to the mma to a point distal to the shunt site with a guidewire. embolization was performed and the mmavf disappeared.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12233501
• MDR Text Key: 264278858
• Report Number: 2029214-2021-00936
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR