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

Model Number	PED-375-16
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-00480, 2029214-2019-0048.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of intraprocedural aneurysm rupture during pipeline flex implantation.Patient presented with a blister aneurysm on the opposite wall of the posterior communicating artery of the right ica.Vessel tortuosity was described as moderate.The landing zone artery size was 3.24mm distal and 3.88mm proximal.It was noted that the physician had been trained to pre-deploy the ptfe protective sleeves on the back table prior to deployment and used this method during this procedure.It was reported that during the procedure, the pipeline flex was deployed in the patient and noted to be "lazy" to fully open.A wire and microcatheter was navigated to expand the device, which was unsuccessful.A balloon was then used to open the pipeline flex fully.After fully opening, the pipeline flex foreshortened -- the aneurysm was not fully covered.Ultimately, three additional flow diversion devices were placed.

• 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: 8642755
• Report Number: 2029214-2019-00481
• Device Sequence Number: 2472878
• Product Code: OUT
• UDI-Device Identifier: 00847536015609
• UDI-Public: 00847536015609
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 07/05/2020
• Device Model Number: PED-375-16
• Device Lot Number: A486754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR