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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
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 two pipeline devices failed to open distally.The patient was undergoing treatment for an unruptured, saccular aneurysm in the ophthalmic segment.The max diameter was 8mm, and the neck diameter was 6mm.The patient's vessel tortuosity was severe.The landing zone was 3.3mm distal and 4.4mm proximal.It was reported that the pipeline was positioned and when the doctor tried to deploy it, the distal end would not open.It was recaptured twice, but it still would not open.A second device was tried, but that also would not open.A third device was used which finally opened.The doctor thought that the vessel tortuosity contributed to the devices not opening.The middle part had been placed in a bend, and more than 50% had been deployed when the devices failed to open.The pipelines were each resheathed two or less times.No additional steps were taken to open the devices.Angiographic results post procedure were said to be good.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (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: 11739713
• Report Number: 2029214-2021-00502
• Device Sequence Number: 3091777
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 06/18/2023
• Device Model Number: PED-450-14
• Device Catalogue Number: PED-450-14
• Device Lot Number: B042472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1