MAUDE Adverse Event Report: Covidien VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Catalog Number	PXB35-06-57-135
Medical Device Problem Codes	Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during peripheral arterial intervention involving the left superficial femoral (sfa), common femoral (cf), and anterior tibial (at) arteries, there was moderate calcification.Lesion stenosis of the sf was 99%, cf was 90% and at was 75%.The lesion length in the sfa was 150mm, lesion length in cf was 40mm and the lesion length in the at was 80mm.The sfa has an artery diameter of 6mm, cf was 6mm and the at was 3mm in diameter.The vessel was pre-dilated with a chocolate balloon.A visi-pro stent was advanced through a 6/7 non medtronic sheath with moderate resistance.The entire stent detached from the delivery system and was radiographically visualized in the distal left anterior tibial artery outside the sheath.The detached stent was expanded with an evercross balloon at 4 atmospheres, and an onyx device was used to secure stent placement.Femoral access was obtained, and treatment of the common femoral and superficial femoral lesions was completed with everflex entrust and in.Pact admiral without issue.The delivery system was removed, and the procedure was completed using a new device.No patient complications have been reported as a result of this event.
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: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50171356
• Report Number: 2183870-2026-00369
• Device Sequence Number: 15917644
• Product Code: NIO
• UDI-Device Identifier: 00643169787735
• UDI-Public: (01)00643169787735(17)281216(10)C241796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Catalogue Number: PXB35-06-57-135
• Device Lot Number: C241796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 12/17/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 176 LB