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

Catalog Number	PXB35-05-17-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
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
It was reported that during treatment of a calcified lesion with severe calcification and moderate tortuosity in a renal vessel, the stent pxb35-05-17-080 visi pro 035 dislodged during use.A 7fr non-medtronic sheath was used.The vessel was pre-dilated.The device was not passed through a previously deployed stent.A renal vessel rupture occurred during deployment of another stent.The visipro stent was safely removed successfully in tandem with the delivery system without injury or intervention, and a new medtronic device was used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the device was returned with the stent separate.The balloon is in a pre-inflated state and confirmed to be 20 mm.There are stent imprint marks visible on the balloon, and the stent is confirmed to be 17 mm, additional information received reported that the visipro stent did not contribute to the vessel rupture and the stent that caused the vessel rupture was not a medtronic stent.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 received: the patient had bilateral renal artery stenosis (r>l).The stent became dislodged inside of the guiding sheath with difficulty to be retrieved.The guiding sheath needed to be removed to keep stent intact.A covered stent was placed across the area of rupture/dissection.Procedure was completed without any other complications and patient recovered well.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: 22157090
• Report Number: 2183870-2025-00289
• Device Sequence Number: 15324529
• Product Code: NIO
• UDI-Device Identifier: 00643169787575
• UDI-Public: (01)00643169787575(17)261010(10)B638426
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/11/2025

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 Catalogue Number: PXB35-05-17-080
• Device Lot Number: B638426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 07/30/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: 81 YR
• Patient Sex: Female