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

Catalog Number	PXB35-05-27-135
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure involving the stent pxb35-05-27-135 visi pro 035 and stent pxb35-05-37-135 visi pro 035, the first stent detached from the balloon at the target lesion and was subsequently pulled back and deployed in the brachial artery, which was not the intended target site.A second stent was then used, but it also detached from the balloon in the aorta just outside of the sheath, was captured, pulled back, and deployed in the brachial artery, again not at the intended target site.There was no injury/intervention associated with this event.The procedure was then aborted.Moderate resistance was encountered when advancing the first device, but no excessive force was used.Both stents remained implanted in the brachial artery.The target vessel was the renal artery/brachial artery with a diameter of 5mm and a cook 6f sheath was used.No embolic protection, pre-dilation, or post-dilation was performed.The instructions for use were followed without issue.No patient injury was reported, and the patient was alive with no injury.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.
Additional Manufacturer Narrative
Additional information: the target lesion was renal artery stenosis.There was greater then 50% lesion stenosis, with a lesion lenght of 40 mm and artery diameter of 6 mm.Due to the deployed of the stents in the non-intended target site a viabahn stent was used to stent the stent pxb35-05-27-135 visi pro 035 and stent pxb35-05-37-135 visi pro 035 to the vessel wall.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
Product analysis: two images were provided for review, which are photographs of angiography screen.The images are poor quality.The first image shows a contrast-enhanced view of the aorta overlying the spine with a mild to moderate left renal artery stenosis.The second image depicts an implanted cardiac device in the left upper chest, as well as a balloon catheter that is visible most likely in the left axillary artery, in its inflated state.The tip of a sheath is visible just proximally.No stents are visualized in either image.Additional information received: only one stent was secured to the wall with a viabahn stent.The second was successfully expanded on its own but not in the intended location.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 ; 091708096
• MDR Report Key: 22459459
• Report Number: 2183870-2025-00363
• Device Sequence Number: 18205871
• Product Code: NIO
• UDI-Device Identifier: 00643169787605
• UDI-Public: (01)00643169787605(17)270822(10)B777860
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/03/2025

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 Catalogue Number: PXB35-05-27-135
• Device Lot Number: B777860
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/14/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/23/2025; 11/03/2025
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male