MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-475-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it was discarded at the site.Attempt to gather additional event details have been made.However our attempts have been unsuccessful.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the pipeline flex tip came apart when it was deployed.They stopped using the device and used a new product.It was discovered that one wire at the tip was oriented toward the proximal side under angiography.Prior to the event, the pipeline was prepared as indicated in the instructions for use.Before removing the protective sleeves, the distal end of the flow diverter had began to deploy insufficiently and it was confirmed that the distal end of the pipeline was frayed.Another attempt to deploy after resheathing was done but it would still not deploy.It was confirmed that one wire strand at the distal end of the pipeline faced the proximal side and the pipeline could not be deployed even when it was unsheathed.The procedure was completed with another device.No patient injury was reported as a result of the procedure.The patient was undergoing embolization treatment of an unruptured aneurysm measuring 7.7mm located in the ic-paraclinoid segment of the internal carotid artery.The distal and proximal landing zone are 3.9mm and 4.8mm.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8422860
• Report Number: 2029214-2019-00205
• Device Sequence Number: 2249511
• Product Code: OUT
• UDI-Device Identifier: 00847536016712
• UDI-Public: 00847536016712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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: 08/06/2020
• Device Model Number: PED-475-18
• Device Lot Number: A503769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR