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

Model Number	PED-400-12
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
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 a report that when attempting to deploy the pipeline it migrated proximal to the aneurysm.As a result the physician attempted to resheath the device to move the whole system forward and cover the neck of the aneurysm but it would not resheath.The product was then removed from the patient and replaced with another of the same model which deployed as expected with no complications.The patient was undergoing surgery for treatment of a distal ica aneurysm.There were no related patient symptoms.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received clarified that there was no migration, but rather that the device jumped back when coming out of the ica terminus.It was confirmed that the devices were prepared and flushed per the ifu.The patient had a mild vessel tortuosity.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8005141
• Report Number: 2029214-2018-00885
• Device Sequence Number: 13867739
• Product Code: OUT
• UDI-Device Identifier: 00847536015814
• UDI-Public: 00847536015814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 08/10/2021
• Device Model Number: PED-400-12
• Device Catalogue Number: PED-400-12
• Device Lot Number: A690840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1