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

Model Number	PXB35-08-27-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use the visi-pro balloon expandable stent during procedure to treat moderately calcified lesion in the proximal common iliac artery.The vessel had severe tortuosity and exhibited 35-45% stenosis.The artery diameter was 8-10mm and lesion length was 25-40mm.A non-medtronic 7fr sheath was used.There was no damage noted to packaging (i.E., shelf carton, hoop/tray) and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.The lesion was pre-dilated with a 7x40 mm pta balloon.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/at lesion.The visi-pro came uncrimped from delivery balloon.The dislodged stent was not removed.The stent was re-accessed and deployed in healthy right common iliac artery.No patient injury.
Additional Manufacturer Narrative
Additional information: there was no deformation noted to the deployed stent.Two sheaths were used to reposition the stent via bilateral femoral access, then used the original balloon to expand the stent once in a desirable location, right common iliac, to complete the procedure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 14160665
• Report Number: 2183870-2022-00145
• Device Sequence Number: 2931897
• Product Code: NIO
• UDI-Device Identifier: 00643169787858
• UDI-Public: 00643169787858
• 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
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 04/29/2022

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: 05/20/2023
• Device Model Number: PXB35-08-27-080
• Device Catalogue Number: PXB35-08-27-080
• Device Lot Number: B027939
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 04/29/2022
• Date Device Manufactured: 05/20/2020
• 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: Male