MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-475-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device has been returned and evaluation is in progress.A follow-up mdr will be submitted when evaluation is complete.Mdrs related to this event: 2029214-2018-00606 and 2029214-2018-00607.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that a pflex (4.75 mm x 25 mm) and an unknown pipeline product failed to open during a procedure to address an unruptured fusiform aneurysm located in the internal carotid artery (ica) posterior communicating artery segment.It was confirmed that the pipeline device and its accessories were prepped according to their indications for use (ifu).It was reported that the health care provider (hcp) attempted to open/flower the pipeline device in the m1 segment multiple times, but the device would not open after unsheathing 2/3 of the device; greater than 50% of the device was deployed.The hcp then attempted to position the device in the ica, but it again would not open.The device was removed from the microcatheter and rhv, and it was noted that the proximal end of the device looked crimped; however, only the middle part of the product was placed in a bend.Another device of the same size was used and it also would not open.The same diagnostics/troubleshooting were performed on the replacement device.It was noted, however, that the replacement device appeared normal upon removal and was not crimped.A 4.5mm x 25mm pipeline device was then used and opened on the first attempt.It was confirmed that usage of the new size resulted in a good outcome.The patient's vessel tortuosity was noted as severe; however, there was no known impact or consequence to the patient.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Correction mdrs related to this event: 2029214-2018-00606, 2029214-2018-00609.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The pipeline flex braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline flex braid was found fully opened with moderately fraying at both ends.No other anomalies were observed.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): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7667701
• Report Number: 2029214-2018-00606
• Device Sequence Number: 1076259
• Product Code: OUT
• UDI-Device Identifier: 00847536016774
• UDI-Public: 00847536016774
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 09/07/2018

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: 10/27/2019
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: A366798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 08/15/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 07/10/2018; 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1