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

Catalog Number	PXB35-07-57-135
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: no deformation noted to the deployed stent.An admiral xtreme was used to expand the 7 mm stent that was dislodged in at the brachial artery.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
Image analysis: the customer returned two video clips and an image.The video depicts the stent implanted in the right common iliac artery, which is patent as demonstrated by contrast flow.The other video depicts the prematurely dislodged stent which is presumed to be within the brachial artery per complaint details and bony landmark visualized.This stent also demonstrated patency as evidenced by contrast flow.The image shows one admiral xtreme carton label and two visi-pro carton labels.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.
Event or Problem Description
Physician attempted to use a visipro balloon expandable stent during treatment of a calcified lesion in the patient¿s right proximal common iliac artery.Lesion exhibited 70% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu (instruction for use) with no issues identified.Embolic protection was not used.The vessel was not pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during delivery to the lesion.The visipro stent was supposed to be deployed at the right common iliac artery but suddenly dislodged from the catheter at the brachial artery during the advancement of the catheter.The dislodged stent was not removed.It was deployed and expanded by a balloon catheter.A replacement 8mm visipro stent was used to treat the target lesion in the right common iliac artery and procedure was completed successfully.No patient injury reported.

• 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: 20755805
• Report Number: 2183870-2024-00426
• Device Sequence Number: 8671519
• Product Code: NIO
• UDI-Device Identifier: 00643169787827
• UDI-Public: 00643169787827
• 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,Followup
• Report Date (Section B): 01/21/2025

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 Expiration Date: 04/26/2025
• Device Catalogue Number: PXB35-07-57-135
• Device Lot Number: B375646
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 01/15/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/09/2024; 01/21/2025
• Date Device Manufactured: 04/27/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown