MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AVIGO; WIRE, GUIDE, CATHETER

Model Number	103-0606-200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information through medwatch form that there was an internal embolization of linear radiopaque material without vessel occlusion, regional spasm, or extravasation.It was alleged that this material represents a fragment from the 014 avigo wire that might have been sustained from resistance met on the initial attempt to pass the wire through the guide catheter to expand the proximal construct.

• Brand Name: AVIGO
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9407018
• Report Number: 2029214-2019-01185
• Device Sequence Number: 19477839
• Product Code: DQX
• UDI-Device Identifier: 00847536004764
• UDI-Public: 00847536004764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 103-0606-200
• Device Lot Number: A853684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/03/2019
• 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