MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number	PED2-325-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Bruise/Contusion (1754); Headache (1880); Vasoconstriction (2126); Stenosis (2263)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a pipeline patient experienced a vasospasm.The patient was hospitalized from (b)(6) 2024.The patient was treated with verapamil, migraine cocktail.The patient recovered/resolved (b)(6) 2024.The adverse event (ae) was possibly related to the disease under study.The ae did not result from a device deficiency.The patient reported to er with a sudden onset headache.The patient was admitted to icu to be treated for vasospasm (intracranial, cerebral vessels).The patient was also treated with a migraine cocktail.The patient was discharged on (b)(6) 2024 as the headaches improved.The patient was being treated for a left c6 ica sidewall aneurysm with a saccular morphology.Aneurysm dimensions: maximum diameter 4.1 mm, dome height 3.8 mm, dome width 3.3 mm and neck size 3.2 mm.The parent artery diameter distal to aneurysm was 2.9 mm.The parent artery diameter proximal to aneurysm was 3.3 mm.Post implant significant stasis at the end of the procedure was noted.Complete neck coverage was reported.Post implant aneurysm occlusion (b)(4) at the end of the procedure was class 3.The access vessel was the femoral right.Rist was not used.The study device was successfully implanted in the patient.Wall apposition was achieved.The side branches were not covered by the pipeline.No device flattening or twisting was reported.
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
Additional information received reported that the patient had bradycardia, headache, and imaging was positive for intracranial vasos pasm.Additionally, there was right femoral bruising noticed on (b)(6) 2024.
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 an infinity 088 guide catheter, navien 058 intracranial support catheter, and phenom 27 microcatheter were used in the procedure.
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 right groin bruising occurred during the hospital stay for the vasospasm.No additional treatment was provided, and event was recovering/resolving.The bruising was not the result of a device deficiency, and the site assessed it as caused by the procedure and not related to the device, antiplatelet medication, or the disease under study.
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 adjudication is causal to procedure and possible to antiplatelet treatment.Mostly contralateral to index aneurysm; may represent reversible cerebral vasoconstrictive syndrome.
Event or Problem Description
Additional information received reported the clinical event committee (cec) adjudicated assessment of the vascular access site bruising concluding the event had a causal relationship to the procedure but was not related to the study device or ancillary devices.Furthermore, the cec adjudicated assessment of the vasospasm event concluding the vasospasm was not related to the index procedure, study device, or antiplatelet medication.Site assessment conclusion remains that the vasospasm is possibly procedure related.
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.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
A related regulatory report and has been merged into this file.All further updates will come through this 202 9214-2024-01839 regulatory report number.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: LASER THERAPY PRODUCT
• 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: 20422228
• Report Number: 2029214-2024-01839
• Device Sequence Number: 20958867
• Product Code: OUT
• 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): 08/12/2026

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 Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B704903
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 11/07/2024; 12/13/2024; 03/13/2025; 10/30/2025; 02/18/2026; 07/20/2026
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/07/2024; 12/03/2024; 01/03/2025; 04/09/2025; 11/26/2025; 03/12/2026; 08/12/2026
• Date Device Manufactured: 03/13/2024
• 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: Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 240 LB
• Patient Race: Black Or African American