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

Model Number	PED2-450-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Flashers (1864); Vitreous Floaters (1866); Hair Loss (1877); Headache (1880); Blurred Vision (2137); Loss of Vision (2139); Paresthesia (4421)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that a pipeline experienced eye floaters and blurred vision.The patient was not treated with a surgical procedure or experienced prolonged hospitalization.The patient was not recovered/resolved.It was noted that the ae was possibly related to the disease under study.New or worsening of existing neurological deficits were noted.The ae did not result from a device deficiency.The patient experienced intermittent eye floaters in the right eye.The patient described them as flashes/fireflies.The patient also reported bilateral blurry vision making reading difficult.The patient was referred to neuroophthalmology.The patient was being treated for a right c6 ica in the side branch with a saccular morphology.Aneurysm dimensions: maximum diameter 2.5 mm, dome height 2.5 mm, dome width 2.5 mm and neck size 2.5 mm.Parent artery diameter distal to aneurysm was 3.8 mm.Parent artery diameter proximal to aneurysm was 4.3 mm.Significant stasis and complete nick coverage was noted at the end of the procedure.Post implant aneurysm occlusion (raymond and roy) was class 3.Access was via femoral right.Rist was not used.The study device was successfully implanted in the subject.Wall apposition was achieved.The side branches were not covered by the pipeline.No device flattening or twisting was identified.  ancillary devices: guide catheter infinity 088, intracranial support catheter navien 058, microcatheter medtronic phenom 027.
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
Additional information received reported that the patient was referred to neuro-ophthalmologist for workup.No specific cause for the vision issues was available.The patient reported hair loss on (b)(6) 2024.It was stated that "hair loss can be from radiation during angio, some patients are more sensitive to it than others but will come back with time." the patient also reported possible bruising post procedure on (b)(6) 2024.It was discussed with the patient that the bruising that they are experiencing may occur while on the blood thinners.
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
Additional information received reported there was no additional treatment or intervention required for the reported bruising and hair loss.It was noted that regarding the patient reported hair loss, "per source document states that it can be from radiation during angio." additionally, bruising may be associated with antiplatelet medications.Hair loss and bruising was not confirmed for this patient.
Event or Problem Description
Additional information received reported that the patient experienced bruising.The patient had not recovered/resolved at the time of the report.No hospitalization or surgical procedure was required.The adverse event (ae) did not result from a device deficiency.Per the source document the patient experienced bruising while on blood thinners.For the hair loss it was stated that it could be from radiation during angio.
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
B5 updated with additional information received.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
Additional information received reported sponsor assessment adjudication.The event of photopsia was attributed causal to the device and possibly to the antiplatelet treatment.Additionally, per neuro-ophthalmology evaluation, bilateral symptoms were likely due to ocular surface drying or refractive error and it was noted that blurred vision is also a reported side effect of clopidogrel (anti platelet medication).
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
Additional information received reported that the patient experienced an ocular migraine on (b)(6) 2025.They reported to the emergency department with 4 minute loss of vision in their right eye, right sided tingling in their face, and stabbing pain in their right eye.Imaging was normal, and they were diagnosed with an ocular migraine.They were treated with intravenous benadryl, reglan, and toradol, at which point the event recovered/resolved.The patient did not experience any further hospitalization at that time.This adverse event was not the result of a device deficiency.The site assessed this adverse event as possibly related to the pipeline, and not related to the disease under study, the procedure, antiplatelet medication, or other devices.Cec adjudicated it as possibly related to the device and not related to the procedure or antiplatelet therapy.

• 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: 20578968
• Report Number: 2029214-2024-02042
• Device Sequence Number: 8649786
• Product Code: OUT
• UDI-Device Identifier: 00763000284541
• UDI-Public: (01)00763000284541(17)260418(10)B551101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/29/2026

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: 04/18/2026
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B551101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 11/26/2024; 12/13/2024; 02/13/2025; 10/30/2025; 08/31/2026
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/20/2024; 01/03/2025; 02/28/2025; 11/21/2025; 09/29/2026
• Date Device Manufactured: 04/19/2023
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 161 LB
• Patient Race: White