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

Model Number	PED-500-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; therefore the clinical observation could not be confirmed, and the event cause could not be determined.It is possible that the patient anatomy (the bend) may have contributed to the reported issue.All products are 100% inspected for damage and irregularities during manufacture.Mdrs related to this report: 2029214-2017-00419, 2029214-2017-00420.
Event or Problem Description
Medtronic received information that during treatment of an aneurysm located in the right internal carotid artery (ica) two pipeline devices would not fully open distally.The first pipeline (ped-500-20) was attempted and it reported that several attempts were made to recapture and redeliver.More than 50 % of the device was deployed when it failed to open.The pipeline was resheathed more than two times and removed together with the microcatheter.A new pipeline (ped-500-18) was used and required balloon angioplasty in order to get the device to fully open at the distal end.As, the distal segment of the pipeline was positioned in a bend.The patient had moderate vessel tortuosity.No patient injury was reported.The aneurysm was saccular with a max diameter of 8 mm and the neck diameter was 5 mm.The distal landing zone was 3.8 mm and the proximal was 4.8 mm.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA
• MDR Report Key: 6478537
• Report Number: 2029214-2017-00420
• Device Sequence Number: 16236033
• Product Code: OUT
• UDI-Device Identifier: 00847536019690
• UDI-Public: 00847536019690
• 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,Followup
• Report Date (Section B): 03/15/2017

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: Health Professional
• Device Expiration Date: 09/19/2019
• Device Model Number: PED-500-18
• Device Lot Number: A345877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR