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

Model Number	105-7100-060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that resistance was felt when the marathon catheter was attempted to be retrieved.The marathon catheter eventually broke at the distal section, as it was stuck in the onyx.The catheter distal section was left in the superior cerebellar artery (sca).The patient did not have neurological deterioration post the intervention.Embolize the sca with onyx18 (about 10 minutes) and the marathon was pulled to retrieve.The intermediate catheter fubuki 4.2 was raised and support was provided, but it was unable to retrieve it.The device was broken during pulling.The injection was interrupted for basic 30 seconds unit.Max120 seconds.There was a backflow that was about 1cm.The devices were prepared and used per the instructions for use (ifu).The arteriovenous malformation (avm) was in the superior cerebellar artery (sca).The vessel anatomy was moderate in tortuosity.

• Brand Name: ONYX AVM
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9706918
• Report Number: 2029214-2020-00142
• Device Sequence Number: 16981951
• Product Code: MFE
• UDI-Device Identifier: 00836462005044
• UDI-Public: 00836462005044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 105-7100-060
• Device Lot Number: A907932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other