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

Catalog Number	PXB35-05-17-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Renal Impairment (4499)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
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 the use of the visipro stent, the stent dislodged and was deployed distal to the lesion in the proximal region of the right renal artery, which was described as having moderate calcification and tortuosity.The artery diameter was 5 mm.A 6fr non-medtronic sheath and 035 guidewire was used.There was no resistance when advancing the device.The vessel was not the issue led to the patient's creatinine levels and blood pressure rising, and kidney function/urine output is decreasing.Attempts to snare the dislodged stent were unsuccessful.The patient was subsequently transferred for evaluation by a transplant team.No deformation noted to the deployed stent.The procedure was completed using a new visipro.The stent remained in the patient, and the balloon catheter was removed.The vessel was post dilated with a 6 x 40 mm non-medtronic device.The issue is still present.
Additional Manufacturer Narrative
Additional information reported that the patient was on dialysis.The patient was going to be if physician did not try to 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
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: 21709393
• Report Number: 2183870-2025-00140
• Device Sequence Number: 4539773
• Product Code: NIO
• UDI-Device Identifier: 00643169787582
• UDI-Public: (01)00643169787582(17)250525(10)B391287
• 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
• 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): 08/06/2025

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 Expiration Date: 05/25/2025
• Device Catalogue Number: PXB35-05-17-135
• Device Lot Number: B391287
• 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: 03/01/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 08/05/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/06/2025
• Date Device Manufactured: 05/26/2022
• 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: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG