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

Model Number	PED-400-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis as the device was implanted in the patient.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Thrombus formation is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that after placement of the pipeline device, the physician opted to wait 10 minutes to ensure no clot formation on the device due to higher pru level.During this period, one of the flush bags ran out and air was introduced into the catheter and into the arteries.Upon angiography it was noted the lack of filling in the anterior cerebral artery (aca) which he believed to be due to an air embolism.The patient was reported to have possible experienced a right aca stroke due to the air embolism.The patient¿s pru level was 253.The pipeline was open with stagnation in the aneurysm.Partial aca blockage due to air embolism.This event occurred during the treatment of a right ica ophthalmic aneurysm that was unruptured.The morphology was saccular, the max diameter was 8mm and the neck was 4mm.The landing zone was 3.8mm distally and the proximal was 4.18mm.The vessel anatomy was moderate in tortuosity.

• 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: 9219942
• Report Number: 2029214-2019-01057
• Device Sequence Number: 2106694
• Product Code: OUT
• UDI-Device Identifier: 00847536015876
• UDI-Public: 00847536015876
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: PED-400-16
• Device Lot Number: A795848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR