MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-350-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned; therefore the event cause could not be determined.Correspondence has been sent out for additional information.Once the device has been received and investigation completed.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the patient had non-serious adverse event of visual problems four days post medtronic flow diverter procedure.Prior to the event, the patient presented with cranial nerve disorder and had pre-operative mass effect.There were no optic nerve symptoms and the mrs was 1.The patient had medtronic flow diverter implanted successfully.There were no problems or adverse events during the procedure.Causal relationship of device to the adverse event could not be denied.There was no causal relationship to the procedure.At 180 day follow up, the optic nerve symptoms were still there (remained unchanged).Mass effect improved.Mrs was 1.Aspirin and clopidogrel administration.At 1 year follow up, the optic nerve symptoms were still there (remained unchanged).Mass effect improved.Mrs was 1.Aspirin and administration.At 2 and 3 year follow up, the optic nerve symptoms were still there (remained unchanged).Mass effect was resolved.Mrs was 1.Aspirin and administration.The patient was undergoing embolization treatment of a saccular aneurysm measuring 27mm x 8mm located in the cavernous sinus segment of the left internal carotid artery (ica).The patient was administered aspirin and clopidogrel preoperative.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9691258
• Report Number: 2029214-2020-00136
• Device Sequence Number: 11198165
• Product Code: OUT
• UDI-Device Identifier: 00836462015753
• UDI-Public: 00836462015753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2018
• Device Model Number: PED-350-35
• Device Catalogue Number: PED-350-35
• Device Lot Number: A080409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: Disability
• Patient Age: 45 YR
• Patient Weight: 56