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

Model Number	PED-275-12
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event has not been returned for evaluation.Correspondence has been sent to the customer for more information and return of the device, but no correspondence has been received regarding the event.Once the device has been received or the additional information is received, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the second pipeline was having difficulty tracking around the patient¿s tortuous vessels and the physician felt it snap inside the marksman microcatheter.The device was removed from the patient.There were no patient symptoms or complications associated with this event.No patient injury was reported.Post procedural angiography showed the aneurysm occluded with stasis.The patient was undergoing embolization treatment for a large/giant wide neck aneurysm.The patient¿s vasculature was moderated in tortuosity.

• 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: 8106122
• Report Number: 2029214-2018-00970
• Device Sequence Number: 1900145
• Product Code: OUT
• UDI-Device Identifier: 00847536014558
• UDI-Public: 00847536014558
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/27/2018

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: 05/18/2020
• Device Model Number: PED-275-12
• Device Lot Number: A462680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1