MAUDE Adverse Event Report: COIDIEN, IRVINE PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-425-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was discarded by the facility, therefore, no product analysis will be performed.Based on the reported information, the pipeline device was used on a patient who had severe vessel tortuosity.There is no evidence suggesting that the device was defective, but rather a procedure related event.The pipeline flex instructions for use (ifu) advises, "precautions ¿ do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis." link mdr's 2029214-2017-01162, 2029214-2017-01163, 2029214-2017-01164.
Event or Problem Description
Medtronic received information that the pipeline flex device failed to open at it mid segment during delivery.This patient had a saccular aneurysm at left ica peri-ophthalmic segment.The aneurysm had maximum diameter of 6mm with neck diameter of 4mm.The landing zone distal and proximal artery sizes were 3.7mm and 4.19mm respectively.The patient's vessel tortuosity was describe as severe.It was reported the device was prepared according to the ifu.During the flow diversion treatment, the physician attempted to place the pipeline flex device in a bend of the vessel with the middle section of the device at the bend.The device was resheathed more than 2 times.The first 1/3 of the pipeline opened without any difficult.When attempting to deliver the pipelines across and proximal to the neck of the aneurysm, the pipeline was difficult to open.This pipeline device was removed from the patient and replaced with new device.No injury to patient reported.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COIDIEN, IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6956639
• Report Number: 2029214-2017-01162
• Device Sequence Number: 1228835
• Product Code: OUT
• UDI-Device Identifier: 00847536016200
• UDI-Public: 00847536016200
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/17/2017

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: Physician
• Device Expiration Date: 10/03/2019
• Device Model Number: PED-425-20
• Device Lot Number: A353343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR