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

Model Number	PED-450-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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 implant the pipeline, the distal end of the stent would not open.The body and p roximal portion up to the re-sheathing pad were opened and well apposed.After re-sheathing and changing the deployment location, the same result was seen.Another re-sheathing attempt was done, and the device was deployed with the system more loaded.Again, just the distal few millimeters would not open.It was noted the stent was not positioned in a bend, and re-sheathing was performed more than twice.The device was removed, and a replacement was used to complete the procedure.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 angiographic results showed a successful procedure.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the right internal carotid artery (ica) with a max diameter of 7 mm and a 4 mm neck diameter.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 203.Ancillary devices include a neuron max 088, 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: 11885399
• Report Number: 2029214-2021-00621
• Device Sequence Number: 19160005
• Product Code: OUT
• UDI-Device Identifier: 00847536016446
• UDI-Public: 00847536016446
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 09/03/2023
• Device Model Number: PED-450-18
• Device Catalogue Number: PED-450-18
• Device Lot Number: B080695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 88