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

Catalog Number	EVD35-07-080-150
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a peripheral artery stenting procedure using the everflex entrust , there was difficulty advancing the stent through the catheter while attempting to treat a moderately calcified, moderately tortuous lesion in the left mid superficial femoral artery.The vessel was pre-dilated with an evercross 6 mm x 40 mm device, and the stent system was advanced over a nitrex.035 400 cm guidewire through a terumo 6 fr destination sheath.Severe resistance was encountered during advancement and excessive force was used.The outer sheath of the stent catheter cracked and separated from the handle during use in the patient.The stent prematurely deployed within the destination sheath rather than in the target location, remained within the sheath without migration, and was reported to be jammed at the end of the sheath as observed under fluoroscopy.The sheath was removed from the patient due to the event, and the device was reported to have been safely removed.The procedure was completed using a new 6 mm x 80 mm everflex device.The patient outcome was reported as alive with no injury and no health consequences or impact.A cut to a medtronic employee was reported when handling the damaged sheath and stent.
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: 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: 25688752
• Report Number: 2183870-2026-00290
• Device Sequence Number: 9709511
• Product Code: NIP
• UDI-Device Identifier: 00821684051689
• UDI-Public: (01)00821684051689(17)290223(10)C278365(20)02
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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 Catalogue Number: EVD35-07-080-150
• Device Lot Number: C278365
• 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: 06/04/2026
• Initial Report FDA Received Date: 07/02/2026
• Date Device Manufactured: 02/24/2026
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG