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

Model Number	PED2-400-18
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient had an internal carotid artery aneurysm, which was accessed through the right radial artery.6f105 distal access catheter to establish access, aneurysm neck width 4mm.  healthcare provider (hcp) used a 3.5-16 blood flow diversion dense mesh stent.After the proximal end of the stent was anchored and opened, when the tail end of the stent had not reached the detachment point, the stent was detached prematurely.Dsa angiography showed that the aneurysm was not completely covered, because the same type of stent was not available, and then it was bridged and implanted with a blood flow diversion dense mesh stent 4-18.After the stent was deployed, dsa angiography showed retention of contrast agent in the aneurysm and the aneurysm was well sealed.The pipeline was used for an approved indication.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured left ophthalmic segment of the internal carotid artery an eurysm with a max diameter of 4.7 mm and a 3.3 mm neck diameter.The landing zone was 2.75mm distally and 2.94mm proximally.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level 200.Angiographic result post procedure was internal carotid artery ophthalmic segment aneurysm.Ancillary devices include a marksman microcatheter and avigo guidewire.
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.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19392194
• Report Number: 2029214-2024-00969
• Device Sequence Number: 7761995
• Product Code: OUT
• UDI-Device Identifier: 00763000284350
• UDI-Public: 00763000284350
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: B649890
• 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: 05/22/2024
• Initial Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 11/03/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Female