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

Catalog Number PXB35-07-37-135

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  Injury  

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 Description

Physician attempted to use a visipro balloon expandable stent with a 6fr x 10cm non-medtronic sheath and a.035 x 260mm non-medtronic guidewire during treatment of a 30mm calcified lesion in the patient¿s left mid common iliac artery.Moderate vessel calcification was reported.Lesion exhibited 90% stenosis.Artery diameter reported as 6mm.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 ifu (instruction for use) was followed during preparation, procedure, post-procedure.Embolic protection was not used.The vessel was pre-dilated with an 5x60 evercross pta balloon.The vessel was not post-dilated.The device did not pass through a previously-deployed stent.Moderate resistance was encountered when advancing the device and excessive force was not used.It was reported stent dislodgement occurred during procedure to put kissing visi-pro stent at common iliac artery in the patient.The right iliac stent went up with no issues.When the left iliac stent was attempted to be moved into place.A little resistance was felt, but stent was thought to be moved into place.The image was magnified and stent was no longer on the balloon.The catheter was removed and the stent was still on the wire.Attempts were made to use a balloon to pull the stent back into the sheath, but did not work.The stent was then attempted to be snared, but the stent ended up crimping and was not able to be removed.After trying multiple ways, the patient was taken to the or and a femoral endarterectomy was performed.The stent was removed and a patch was put around the artery.Procedure was aborted.Patient is doing good now.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Type of Device: 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: 19057619
• MDR Text Key: 339554715
• Report Number: 2183870-2024-00115
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787803
• UDI-Public: 00643169787803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PXB35-07-37-135
• Device Lot Number: B230244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG