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

Catalog Number	PXB35-07-57-080
Medical Device Problem Codes	Difficult to Insert (1316); Compatibility Problem (2960); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis the device was returned stuck on a 0.035¿ guidewire.Approximately 25mm of the deformed and detached stent was returned, the balloon was detached from the device and was stuck on the guidewire, and there was bunching on the shaft, the luer and strain relief were also detached from the device and were not returned, 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 the stent pxb35-07-57-080 visi pro 035 was intended to be used to treat plaque in the left proximal common iliac artery.During the procedure, there were difficulties inserting the device, and moderate resistance was encountered when advancing it.It was stuck, difficult to push forward or pull back on the wire, so the physician could not get it out of the patient.The physician had to pull the entire visipro out with the terumo sheath with no additional intervention required to remove.The vessel was pre-dilated with a non-medtronic 7x60x80 dilation device, the artery diameter was measured at 7mm, and the degree of tortuosity was assessed as moderate.A 45cm 6fr non-medtronic sheath and a 180cm non-medtronic guidewire were used.The procedure was completed using a new everflex 8x80x120 device.No patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that the stent was damaged.

• 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: 22517234
• Report Number: 2183870-2025-00371
• Device Sequence Number: 18157288
• Product Code: NIO
• UDI-Device Identifier: 00643169787810
• UDI-Public: (01)00643169787810(17)270701(10)B754125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/16/2025

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: PXB35-07-57-080
• Device Lot Number: B754125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 07/01/2024
• 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
• Patient Sex: Female