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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2020

Event Type  Injury  

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 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
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9706918
• MDR Text Key: 189206521
• Report Number: 2029214-2020-00142
• Device Sequence Number: 1
• Product Code: MFE
• UDI-Device Identifier: 00836462005044
• UDI-Public: 00836462005044
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 105-7100-060
• Device Lot Number: A907932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2019
• 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