MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-425-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
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 information that a pipeline flex device did not open during a procedure.The patient was undergoing flow diversion of a small unruptured saccular posterior communicating aneurysm that was previously coiled and recurred.Vessel tortuosity was described as severe.It was reported that while attempting to deploy the device the distal end of the device would not open.The physician decided to remove the device and use another.The pipeline resheathed and removed with the microcatheter.There were not any patient symptoms or complications associated with this event.No images available for review.Yes, dapt (dual antiplatelet treatment) was administered.The pru lever was 68.The angiographic result was very good post procedure.No patient injury was reported.The pipeline and any accessory devices were prepared as indicated in the ifu.The pipeline was positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.There was not any additional steps or other devices required to open the pipeline.Terumo 8fr, neuron max, phenom 27.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8142510
• Report Number: 2029214-2018-01032
• Device Sequence Number: 19069988
• Product Code: OUT
• UDI-Device Identifier: 00847536016057
• UDI-Public: 00847536016057
• 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): 12/07/2018

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: 07/19/2021
• Device Model Number: PED-425-10
• Device Catalogue Number: PED-425-10
• Device Lot Number: A678863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1