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

Catalog Number	PXB35-06-57-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an attempted advancement of the stent pxb35-06-57-135 visi pro 035 to a severely calcified, 70% stenosed proximal common iliac artery lesion, the device tip detached.The device/component embolization most likely occurred at the distal external iliac during the attempted passage.The lesion was pre-dilated with a 5mm admiral xtreme pta balloon.The detached portion of the device did not remain in the patient, as the catheter was intact upon removal.The procedure was completed using a self-expanding stent instead.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 tip was damaged, not detached.The device safely removed from the patient, the complete part of the stent delivery system was safely removed without issue with no patient injury.Image analysis: two images were provided for evaluation.The first image shows the shipping carton.The second image shows the distal section of the device.The stent is observed to have migrated distally and is deformed.The catheter tip is not visible, as it is obscured by the deformed 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.

• 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: 24363036
• Report Number: 2183870-2026-00078
• Device Sequence Number: 9987290
• Product Code: NIO
• UDI-Device Identifier: 00643169787735
• UDI-Public: (01)00643169787735(17)271030(10)B811384
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: PXB35-06-57-135
• Device Lot Number: B811384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 10/30/2024
• 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 Sex: Unknown