MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-115-08MP
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
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 for the ruptured aneurysm of the right internal carotid artery c6 segment, the blood flow diversion dense mesh stent ped-475-20, lot number: b709537, was selected to implant.During the deployment process, the tail end of the stent could not open normally.Because the tail end of the stent could not open, the stent was retrieved and deployed again, but it was found that the stent could not be retrieved, and then the whole system was removed from the body.There was failure to open in the proximal section.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed and removed from the patient with the microcatheter.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an approved (on-label) indication.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured right c6 aneurysm with a max diameter of 6 mm and a 5 mm neck diameter.The landing zone was 3.5 mm distal and 4.9 mm proximal.It was noted the patient's vessel tortuosity was moderate.There was normal postoperative angiography.Additional information received reported that the patient was being treated for an unruptured aneurysm.The cause of the failure to open and resistance was not determined.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21895946
• Report Number: 2029214-2025-01054
• Device Sequence Number: 11645434
• Product Code: DQY
• UDI-Device Identifier: 00847536017924
• UDI-Public: 00847536017924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2026
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B716090
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/23/2025
• Date Device Manufactured: 04/09/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Male