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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/25/2020

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.Monitoring and trending this type of event.Please reference mdr# for catheter 2029214-2020-00632.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic microcatheter distal shaft was stuck and separated from the catheter body as they physician was removing it after medtronic liquid embolic injection.Considering the risk of removing the separated part, it was pushed to the vicinity of the liquid embolic cast where it remains in the patient.The procedure was completed at this point.Post procedure, the patient woke up from anesthesia and there was no sequelae at the time of this report.The patient was undergoing embolization treatment of a dural arteriovenous fistula (davf) in the occipital artery (oa).The vascula ture was normal in tortuosity.Diameter of access vessel was unknown.It was reported the microcatheter was broken at the distal part of the shaft, but no other damage to microcatheter.The break was due to the tip sticking to the liquid embolic.The broken catheter distal tip was left and remains near the oa cast.There were no additional surgical or medical procedures performed.There was no vasospasm.

• 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: 10215885
• MDR Text Key: 201151340
• Report Number: 2029214-2020-00633
• Device Sequence Number: 1
• Product Code: MFE
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

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: UNK-NV-ONYX
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2020
• Initial Date FDA Received: 06/30/2020
• 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): Disability