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

Model Number	PED2-375-14
Medical Device Problem Codes	Positioning Failure (1158); Unintended Ejection (1234); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id ped2-375-16 (lot: b781634); medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a neurovascular procedure involving a pipeline embolization device, the device was partially deployed in the wrong position within the right hemisphere, c6 segment, bifurcation branch.The aneurysm was unruptured with a saccular morphology, a maximum diameter of 2.8mm, and a neck diameter of 2.0mm.The landing zone artery size was 3.4mm distally and 3.7mm proximally.An attempt was made to resheath and advance the device in the parent vessel, but it could not pass over the distal wire.Consequently, the device was removed, and a new one was used.The patient's medical history included a family history of stroke/tia, controlled hypertension, vitamin d deficiency, covid-19, a history of transient ischemic attack, environmental and seasonal allergies, acquired hypothyroidism, bipolar affective disorder in remission, asthma, chronic fatigue, constipation, insomnia, menopausal symptoms, migraines, recurrent cold sores, urge incontinence of urine, and urinary tract infectious disease.The outcome of the procedure was not specified.Complete stasis and neck coverage was noted at the end of the procedure.Post implant aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.The access was via femoral right.Rist was not used.The study device was successfully implanted in the subject.Wall apposition was achieved after replacement.Side branches were covered by the pipeline device (ophthalmic).No device flattening or twisting was noted.Ancillary devices: guide catheter 7 french 072 armadillo, microcatheter medtronic phenom 027.
Event or Problem Description
Additional information was received.There were no reported issues identified with the catheter used.Site reported complete wall ap position, neck coverage at the end of procedure.R & r was class 3.Complete stasis.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the site¿s query response, the year 1 dsa imaging on (b)(6) 2025 was initially reviewed for the wrong aneurysm and classified as raymond and roy class 3.Upon further review by dr.(b)(6) and the team, it was determined that the correct study aneurysm is class 1.No symptoms or actions were reported in association with the initial non-occlusion finding.
Additional Manufacturer Narrative
Update b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20892742
• Report Number: 2029214-2024-02269
• Device Sequence Number: 7902619
• Product Code: OUT
• UDI-Device Identifier: 00763000284244
• UDI-Public: (01)00763000284244(17)250203(10)B333314
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/22/2026

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: 02/03/2025
• Device Model Number: PED2-375-14
• Device Catalogue Number: PED2-375-14
• Device Lot Number: B333314
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 02/06/2025; 11/25/2024; 06/15/2026
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/10/2025; 02/07/2025; 12/17/2025; 06/22/2026
• Date Device Manufactured: 02/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White