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

Model Number PED2-450-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12461557
• MDR Text Key: 271645828
• Report Number: 2029214-2021-01159
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: 00763000284503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B208340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 82