MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	EVD35-07-060-080
Medical Device Problem Codes	Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2025
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 a procedure involving an everflex entrust stent in the right common iliac artery, severe resistance was felt by the physician, and the delivery system could not be advanced to the target lesion.A non medtronic sheath and guidewire were used.The target lesion was a calcified lesion in the distal region of the right iliac artery.The artery was 7mm in diameter with severe tortuosity and moderate calcification.The physician attempted to advance.The stent prematurely deployed without the removal of the red safety, locking mechanism, or turning the thumb wheel.The physician navigated a balloon to deploy the stent in the artery, but dislodgement and elongation of the stent were noted.The procedure was completed using a new device, which was not a medtronic device.The vessel was pre-dilated with an evercross.035 5 x 100 dilation device, and post-dilation was performed.The stent remains in the patient, and no attempts were made to remove it.The physician was able to fully deploy the stent.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the device was returned with the red safety tab still in the device.The device was confirmed from the strain relief as 60 mm.A kink was observed along the silver outer sheath, at approx.60 mm from the distal end of the device, (photo 3).The unadvanced stent pusher could be visualised in the sheath at approx.63 mm.The red tab was removed, and the handle was opened, and the pull wire was still attached to the device and deployment wheel, no kinks or abnormalities noted on the inner, (photo 5).The stent pusher was advanced out of the outer sheath and biologics were noted on the pusher.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: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 22034996
• Report Number: 2183870-2025-00243
• Device Sequence Number: 9504668
• Product Code: NIP
• UDI-Device Identifier: 00821684051214
• UDI-Public: (01)00821684051214(17)270429(10)B724633
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• 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
• Report Date (Section B): 07/26/2025

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 Catalogue Number: EVD35-07-060-080
• Device Lot Number: B724633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/28/2025
• Date Device Manufactured: 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female