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

Model Number	PED2-450-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a pipeline patient experienced bradycardia.No hospitalized or a prolongation of an existing hospitalization was required.The patient was given chest compressions briefly as they woke up from vagal mediated bradycardia.The patient recovered/resolved.The adverse event did not result from a device deficiency.The subject was noted on (b)(6) 2024 to have bradycardia.The subject was noted to "have a propensity for vagal attacks" and it was attributed to vagal mediated bradycardia by cardiology.It was noted that the event was possibly related to the study procedure.The patient was being treated for a left c5 ica aneurysm in the vessel sidewall with a saccular morphology.Aneurysm diameter: maximum diameter 4 mm, dome height 4 mm, dome width 4 mm and neck size 3 mm.Parent artery diameter distal to aneurysm was 3.8 mm.Parent artery diameter proximal to aneurysm was 4.5 mm.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 vessel was the femoral right.Rist was not used.The study device was successfully implanted in subject.Wall apposition was achieved.Side branches were covered by pipeline device (c6).No device flattening or twisting was noted.Ancillary devices: guide catheter armadillo 072, support catheter simmons-2 5fr, microcatheter 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.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 the patient was discharged to home/self-care.Chest compressions given briefly as subject woke up from vagal mediated bradycardia.
Event or Problem Description
Additional information received reported that the source documents stated that the cardiologist believed the bradycardia was ¿most likely vagal mediated bradycardia.¿.
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 source documents stated that the cardiologist believed the bradycardia was ¿most likely vagal mediated bradycardia.¿.
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 cec adjudicated as serious.Cec adjudicated as possible to index procedure.

• 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: 20207664
• Report Number: 2029214-2024-01574
• Device Sequence Number: 7769850
• Product Code: OUT
• UDI-Device Identifier: 00763000284510
• UDI-Public: 00763000284510
• 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
• 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): 05/09/2025

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: 01/31/2026
• Device Model Number: PED2-450-14
• Device Catalogue Number: PED2-450-14
• Device Lot Number: B618831
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 10/09/2024; 10/09/2024; 04/28/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/31/2024; 10/31/2024; 05/09/2025
• Date Device Manufactured: 09/15/2023
• 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: Life Threatening
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White