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

Model Number	PED-450-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed.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 that a pipeline flex device did not open during a procedure.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline had not been positioned in a bend.The device had been resheathed less than two times.The device was not implanted.There were no patient symptoms or complications associated with this event.The angiographic result post procedure was good.The patient was undergoing embolization treatment of a small unruptured saccular aneurysm located in right ophthalmic segment, measuring 4mmx3mm, landing zone distal 3.75mm proximal 4.4mm.The vessel was observed moderately tortuous.The pipeline and any accessory devices were prepared as indicated in the ifu.

• 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: 8908873
• Report Number: 2029214-2019-00858
• Device Sequence Number: 286110
• Product Code: OUT
• UDI-Device Identifier: 00847536016385
• UDI-Public: 00847536016385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• 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): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: PED-450-14
• Device Lot Number: A811476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1