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

Model Number	PED-475-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.Related mdrs for this event: 2029214-2019-00892 2029214-2019-00893.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that a pipeline flex device did not open at the distal segment during a procedure.Second pipeline flex device tip broke of the pushwire.The patient underwent embolization treatment for an unruptured saccular aneurysm located in left cavernous segment.Measuring 8mmx5mm, landing zone distal 4.5mm proximal 3.5mm.The vessel was moderately tortuous.It was reported that the guidecatheter was placed through the max sheath and placed into the petrous segment for support.The medtronic microcatheter was placed into the middle cerebral artery (mca) and the first device was advanced through the catheter.The pipeline flex device advanced normally but the device failed to open distally.The device was re-sheathed several times in an effort to get the device to open.After several attempts the device was removed and a new device was inserted.The second pipeline device (same lot number) was advanced through the same catheter to the tip of the catheter.The pipeline device was deployed per ifu and as the device was being dragged back into position, the distal end of the pipeline fell into the aneurysm.The pipeline was constrained to allow the device to be advanced again and resistance was noticed while the pipeline was being re-sheathed.The resistance changed suddenly, and it was noticed that the tip wire was disconnected from the delivery system.The physician removed the delivery system, catheter and guidecatheter as a unit and all parts of the system were removed successfully without incident.It should be noted that the pipeline device was found in the guidecatheter and the tip wire had to be removed from the femoral sheath with hemostats.The physician then completed the case using a non-medtronic stent and coils.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Patient was treated with stent/coil and was angiographically fine post procedure.

• 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: 8955959
• Report Number: 2029214-2019-00892
• Device Sequence Number: 11273175
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/03/2019

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: 04/18/2022
• Device Model Number: PED-475-10
• Device Lot Number: A817769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR