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

Model Number	PED2-350-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Edtronic received a report that post procedure image of radiopaque artifact distal to aneurysm.The pipeline was used on-label and was prepared as indicated in the ifu.  no patient symptoms or further complications were reported as a result of this event. dapt (dual antiplatelet treatment) was administered, pru level was 104.  the patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left pcom with a max diameter of 3mm and a 2mm neck diameter.Landing zone was 3.1mm distally and 3.6mm proximally.It was noted the patient's vessel tortuosity was minimal.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14023270
• Report Number: 2029214-2022-00590
• Device Sequence Number: 14986731
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 06/21/2024
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B224683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/06/2022
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male