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

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Citation: y.He, y.Ding, w.Bai, t.Li, f.K.Hui, w.-j.Jiang, and j.Xue ¿safety and efficacy of transvenous embolization of ruptured brain arteriovenous malformations as a last resort: a prospective single-arm study¿ https://doi.Org/10.3174/ajnr.A6197.The device will not be returned for evaluation as it was consumed in the event.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.Mdrs related to this event: 2029214-2020-00674 2029214-2020-00675 2029214-2020-00676 2029214-2020-00677.If information is provided in the future, a supplemental report will be issued.

Event Description

Y.He, y.Ding, w.Bai, t.Li, f.K.Hui, w.-j.Jiang, and j.Xue ¿safety and efficacy of transvenous embolization of ruptured brain arteriovenous malformations as a last resort: a prospective single-arm study¿ https://doi.Org/10.3174/ajnr.A6197 medtronic received information regarding onyx through literature review.Immediately after the procedures, complete obliteration was achieved in 16 cases, with an obliteration rate of 84.2% in the 19 technically feasible cases and 76.2% in all 21 cases.Follow-up angiography was performed from 1 to 15 months after embolization.Stable obliteration was confirmed in 18 patients.No recurrence was noted.One avm located in the parietal lobe and basal ganglia showed progressive occlusion.The procedures included 1 or 2 microcatheters (marathon, apollo, echelon, or headway duo) placed as close as possible to the nidus of the avms.At the completion of the procedure, the microcatheter injecting onyx was cut at the level of the jugular sheath.A single microcatheter was used in 3 patients and 2 microcatheters in 16 patients.The microcatheters for onyx injection were retained in all patients except one.

• Brand Name: ONYX
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10249117
• MDR Text Key: 201275148
• Report Number: 2029214-2020-00675
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2020

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: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other