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

Model Number	PED-450-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
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 report that 2 pipeline devices failed to open at the distal tip.The patient was being treated for 2 aneurysms.Left internal carotid artery (ica) terminus aneurysm (previously clipped) and supraclinoid aneurysm proximal to the ophthalmic.The distal aneurysm was successfully treated with a pipeline.However, while attempting to treat the lower aneurysm, the pipeline failed to be released from the pts sleeves.This event was reported to have occurred with 2 pipeline devices.A new pipeline 450-14 was used to treat the patient.The anatomy through the internal carotid artery was very tortuous.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8110922
• Report Number: 2029214-2018-00983
• Device Sequence Number: 13931493
• Product Code: OUT
• UDI-Device Identifier: 00847536016354
• UDI-Public: 00847536016354
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/28/2018

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: 09/11/2021
• Device Model Number: PED-450-12
• Device Catalogue Number: PED-450-12
• Device Lot Number: A706317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR