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

Catalog Number	EVD35-07-060-120
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis the device was returned with the red safety lock pin out of the device, the device was confirmed as 60mm, the device was returned with approx.3mm of the stent exposed the deployment wheel was rotated, the stent able to advance out of the device, the stent was examined and no abnormality noted 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 the everflex entrust, the physician mentioned that the device felt unusual going into the body and had concerns over deploying it.Moderate resistance was met during advancement.The device was intended to a lesion in the superficial femoral artery.The target lesion was calcified with minimal tortuosity, measuring 60mm in length and 7mm in diameter.The vessel was pre-dilated and post-dilated, and the device was not passed through a previously deployed stent.The device was safely removed, and the procedure was completed using a new everflex.No patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that the stent was partially deployed.

• 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: 22042239
• Report Number: 2183870-2025-00246
• Device Sequence Number: 15773154
• Product Code: NIP
• UDI-Device Identifier: 00821684051436
• UDI-Public: 00821684051436
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/19/2025

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: 08/03/2025
• Device Catalogue Number: EVD35-07-060-120
• Device Lot Number: B426305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 08/04/2022
• 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