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

Model Number PED-500-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Brain Injury (2219); No Code Available (3191)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

The reported adverse event of ocular motility disorder and mass effect was reported to have occurred approximately two years post uneventful pipeline embolization procedure.The patient's mrs post procedure was 0.The patient's 1 month, 6 month, and 1 year follow up did not show any changes.At the two year follow-up, the mrs changed from 0 to 1 and the adverse events were reported.It was also noted that the adverse events were not related to the device and not related to the procedure.Correspondence has been sent out for more information regarding the event.Once received, a supplemental will be submitted.Reference mdr# 2029214-2018-00688.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient developed ocular motility disorder approximately two years post procedure involving two flow diverters.The patient underwent uneventful flow diverter embolization treatment for an unruptured saccular aneurysm measuring 25mm with neck width of 13.5mm located in the paraclinoid segment of the left internal carotid artery (ica) approximately two years ago.There was not device malfunction and the flow diverters were implanted successfully in the intended location.The mrs was 0 post procedure.During follow up 7 days post procedure, the mrs was still 0 and there were no adverse events reported.The patient continued with 1 month, 6 month, and 1-year follow-up yielding the same results as the 7 day follow up.No adverse events.During the 2-year follow up, the patient¿s mrs had changed from 0 to 1 and there was some mass effect.The patient had developed an adverse event of ocular motility disorder and the occurrence was unknown.The adverse event was not labeled as device related or procedure related.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7737197
• MDR Text Key: 115647435
• Report Number: 2029214-2018-00689
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• 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,Followup
• Report Date: 10/04/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: PED-500-18
• Device Lot Number: A067099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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
• Patient Age: 67 YR