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

Model Number	PED2-425-12
Medical Device Problem Codes	Structural Problem (2506); Activation Failure (3270); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Bruise/Contusion (1754); Hemorrhage/Blood Loss/Bleeding (1888); Stenosis (2263); Numbness (2415)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the patient had 6-month imaging done at day 180.Crf noted class 3 stenosis and complete wall apposition not achieved.Site did a retreatment on subject's residual aneurysm at 6 months.There was no assessment for product/therapy/procedure relatedness made by the investigator, sponsor, or cec.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the event relatedness to the disease under study was "probable".The site assessed the event as probably related to the antiplatelet medication and not related to the device or procedure.Dsa on (b)(6) 2023 reported persistent filling of previously flow diverted left ica clinoid segment aneurysm measuring 4.3x4x2.3mm.
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 was received that the site responded to safety query regarding reason for icu admission post retreatment and stated ¿ normally post-op course for recovery, discharged directly from icu¿.
Event or Problem Description
Additional information was received reporting the patient's prolonged hospitalization was due to retreatment.Medtronic received a report that the patient underwent target treated aneurysm retreatment onset date (b)(6) 2023.The retreatment resulted in new hospitalization (icu) from (b)(6) 2023 to (b)(6) 2023.A second pipeline device (lot b561271) was placed into original.The aneurysm was still filling and the patient was experiencing bruising due to dual antiplatelet therapy (dapt).The treating physician decided to retreat the aneurysm so that they could stop dapt.This event did not lead to congenital anomaly, death, disability, or medical intervention and was not considered life-threatening per the site.The patient recovered and the issue resolved.The patient was undergoing surgery for treatment of a saccular, left internal carotid artery (ica) c7 side branch aneurysm with a max diameter of 7mm and a 4mm neck diameter.The aneurysm dome height was 7mm and width 4mm.Parent artery diameter distal to aneurysm was 3.8mm.Parent artery diameter proximal to aneurysm was 4.1mm.There was no stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.Post implant aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.Aneurysm symptoms included altered mental status, localized headache, migraines, nausea/vomiting, and photophobia (sensitivity to light.).
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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 was received that the clinical events committee (cec) assessed the event as possibly related to the procedure device and apt.
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
Medtronic received a report that a pipeline patient experienced bruising.The adverse event did not result in the subject being hosp italized or a prolongation of an existing hospitalization.The patient was taken off plavix on (b)(6) 2024.The patient was recovering/resolving.The patient had been experiencing increased bruising since initial treatment procedure on (b)(6) 2023.The patient experienced a headache.The patient was prescribed gabapentin.The headaches were constant which diffuse in location occasionally causing bi temporal pain and blurry vision that clears with blinking.The site reported that the headache was unrelated to procedure, dapt, or the device.
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
Additional information received reported core-lab assessed residual aneurysm for 1-year follow-up with no stenosis.Site reported r & r class 2 with no current retreatment scheduled.It was unknown if there was nay impact to the patient.It was unknown if there was any additional medical intervention required to prevent permanent injury or impairment.
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 it was determined that this ae was related to baseline condition of headaches.The patient the patient experienced heavy periods since starting plavix.The patient started in (b)(6) 2023 and worsened early (b)(6) 2023.Norethindrone was prescribed (b)(6) 2023 and stopped (b)(6) 2023.The access vessel was the femoral right.Rist was not used.The study device was successfully implanted in the subject.Wall apposition was achieved.Side branches were covered by the pipeline (pcoa, sha, opha).No device flattening or twisting was noted.Localized right lateral thigh numbness since imaging procedure done on (b)(6) 2023 was noted.Ancillary devices: guide catheter used infinity 088, intracranial support catheter sofia and phenom plus, 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 adverse event (ae) was possibly related to the device/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 patient experienced thigh numbness at the procedural access site.
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 retreatment procedure was possibly related.

• 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 ; +1(763)526-5677
• MDR Report Key: 18583600
• Report Number: 2029214-2024-00166
• Device Sequence Number: 8517791
• Product Code: OUT
• UDI-Device Identifier: 00763000284411
• UDI-Public: (01)00763000284411(17)260313(10)B532189
• 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: 2023
• 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: 03/13/2026
• Device Model Number: PED2-425-12
• Device Catalogue Number: PED2-425-12
• Device Lot Number: B532189
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 01/30/2024; 02/16/2024; 03/20/2024; 06/05/2024; 08/07/2024; 09/04/2024; 09/10/2024; 10/04/2024; 10/30/2024; 12/13/2024; 01/14/2025; 03/12/2025; 07/20/2026; Not provided; 08/31/2026
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/16/2024; 03/14/2024; 04/10/2024; 06/28/2024; 08/20/2024; 09/11/2024; 09/27/2024; 10/30/2024; 11/13/2024; 01/09/2025; 01/31/2025; 04/07/2025; 08/12/2026; 08/19/2026; 09/29/2026
• Date Device Manufactured: 03/14/2023
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 218 LB