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

Model Number	PED2-450-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Date of Event	09/06/2021
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
Medtronic received information reporting that on (b)(6) 2021, a pipeline flex with shield (model: ped2-450-20, lot: b209283) was being implanted in attempts to treat 2 unruptured supraclinoid left internal carotid artery (ica) aneurysms.After the pipeline was delivered, there was some foreshortening resulting in incomplete neck coverage of the more distal aneurysm.There was no friction or difficulty during delivery or positioning.The tip of the catheter was not moved during deployment.The pipeline did not jump during deployment but missed the landing zone.A second, shorter pipeline flex with shield (model: ped2-450-12, lot: b208340) was then placed distally in the proximal m1 for full coverage.Both devices opened well with good apposition seen in final angio.The patient was prescript dual antiplatelet treatment (dapt) - aspirin and brillinta.2 days after discharge, the patient began experiencing stroke symptoms and was readmitted on (b)(6) 2021.On (b)(6) 2021, the patient was admitted to intensive care (icu) and a thrombectomy was done.Occlusion recurred on (b)(6) 2021 and another thrombectomy was successfully performed.

• 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
• MDR Report Key: 12461557
• Report Number: 2029214-2021-01159
• Device Sequence Number: 3780106
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: 00763000284503
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/13/2021

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: 05/19/2024
• Device Model Number: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B208340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/13/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 82