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 Problem Paresis (1998)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sabino luzzi, mattia del maestro, renato galzio; acta neurochirurgica supplement; 2021; 132; the preoperative functional downgrading of brain avms; doi.Org/10.1007/978-3-030-63453-7_16.Medtronic received information in a literature article of a review of 31 patient's treated with onyx 18 and marathon catheters had complications.The average age was 36.9 and the male to female ration was 2.8.  thirty-one arteriovenous malformations (avms) were embolized in 51 endovascular procedures. only low-density onyx18 was used as the embolic agent in the present series.Through a transarterial transfemoral approach, a flow-directed microcatheter and a tapered mic roguidewire were advanced until the nidus.After a superselective catheterization of the main arterial feeders, a microcatheter was moved throughout the target feeders inside the nidus.While preferring the deep-seated parts, onyx was injected with a flow rate of 0.1 ml/s by means of the ¿plug and push¿ technique. the first session was always aimed to achieve the widest obliteration possible volume, stopping, however, after having reached the safest final possible result.Two mechanical and one hemodynamic endovascular complications were recorded during the embolization sessions; the mechanical ones both consisted of a catheter stuck, while a hemiparesis occurred in a single patient 8 h after the procedure. the estimated embolization-related morbidity rate was 3.2% with zero mortality. at the 6-month follow-up, the overall outcome was as follows: mrs 0¿2, mrs 3, and mrs > 4 in 77.5%, 19.3%, and 3.2% of the patients, respectively.Two patients (6.4%) had a small remnant, which underwent radiosurgery.As grade iii typing concerns, the best outcome was achieved in small and medium-deep avms.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13815313
• MDR Text Key: 292486618
• Report Number: 2029214-2022-00434
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/18/2022
• 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: 37 YR
• Patient Sex: Male