MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that when the coil was about halfway out it kicked the microcatheter out of place due to resistance/being stuck.The physician attempted to pull the coil back into the microcatheter but it broke, with part of the coil going into the left hepatic and unable to be retrieved.It was noted that the coil apparently deployed in the body.Prior to the issue two coils had been placed successfully without issue.It was guessed by the manufacturer representative (rep) that the coil may have stretched and released.The patient was undergoing surgery to treat an unruptured, saccular aneurysm.It was noted that the patient's vessel tortuosity was moderate and their blood flow was normal.The devices were prepared as indicated per the ifu; however, a continuous flush was not used.There was no attempt to reposition or detach the coil.Ancillary devices include a bsci high flow guide catheter.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8046962
• Report Number: 2029214-2018-00923
• Device Sequence Number: 1625161
• Product Code: KRD
• UDI-Device Identifier: 00847536013704
• UDI-Public: 00847536013704
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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: 01/21/2021
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: A585359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/07/2018
• 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
• Patient Age: 61 YR