MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-500-12
Medical Device Problem Codes	Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2020
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 the 5.0x12 pipeline device was introduced to the vessel distal to the aneurysm.However, the distal portion of the stent would not open after several attempts.The stent was removed, and during retrieval, the delivery pushwire separated from the implant near the hub of the phenom 27 microcatheter.The stent was removed along with the catheter, and replacement products were used to complete the procedure.It was noted the physician used significant force to remove the pipeline due to resistance in the hub of the catheter, and was unknown if there was any damage to the catheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed an implanted pipeline with good apposition and coverage of the neck of the aneurysm.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left cavernous segment of the internal ca rotid artery with a max diameter of 12 mm and a 5 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.Ancillary devices include a neuron max sheath, phenom plus guide catheter, phenom 27 microcatheter.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10733736
• Report Number: 2029214-2020-01055
• Device Sequence Number: 11044730
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/26/2020

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: 10/14/2022
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: A914817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1