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

Model Number	PED2-400-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a pipeline patient experienced dep vein thrombosis.The patient was hospitalized (b)(6) 2024.The patient received apaxiban.The patient recovered/resolved on (b)(6) 2024.The adverse event (ae) was not related to the disease under study or result from a device deficiency.The patient reported to emergency department with bilateral lower leg edema.A bilateral venous ultrasound showed an acute dvts.The patient was being treated for a right ica c6 side branch aneurysm with a saccular morphology.Aneurysm dimensions: maximum diameter 8.7 mm, dome height 7.8 mm, dome width 8.7 mm and neck size 5 mm.Parent artery diameter distal to aneurysm was 3.5 mm.Parent artery diameter proximal to aneurysm was 3.9 mm.Significant stasis was noted at the end of the procedure.Complete 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.Wall apposition was achieved.The study device was successfully implanted in subject.Side branches covered by pipeline device were opha, sha.No device flattening or twisting was noted.  ancillary devices: guide catheter infinity 088, intracranial support catheter 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 was received.Regarding the cause of the deep vein thrombosis, source documentation from ed visit stated, ¿exam with bilateral 2+ pitting edema to approximately 4 in below her patella with no signs of active infection no increased warmth.She has active 2+ pulses on her dorsal pedal bilaterally.Her lung sounds were clear and equal.I suspect that this is likely venous insufficiency given that the symptoms improve when she is lying down and she has no history of heart disease and lung exam was normal.¿.
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 recieved reported it was adjudicated the event was not related to device, antiplatelet medication, or 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: 20262999
• Report Number: 2029214-2024-01606
• Device Sequence Number: 12836636
• Product Code: OUT
• UDI-Device Identifier: 00763000284343
• UDI-Public: 00763000284343
• 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
• Report Date (Section B): 12/19/2024

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: 02/23/2026
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: B524169
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 11/25/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/19/2024
• Date Device Manufactured: 02/24/2023
• 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
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic