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

Catalog Number	EVD35-06-150-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the stent was not deployed in the target location product analysis the device was returned with the no red safety lock pin, no strain relief sizing section and a portion of the stent was observed to be exposed, the device was confirmed as 150mm enclosed within the sheath, approx 11mm of the stent was exposed from the device, a kink was observed on the silver outer sheath, which measured approx.24.8cm from the distal tip end of the device the device was returned with handle dismantled where the pull cable was attached to the deployment wheel but detached from the rest of the device, 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.
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 treatment of a calcified, moderate lesion measuring 150 mm in the right distal superficial femoral artery, the everflex entrust device exhibited a thumb wheel malfunction and the cable detached from the blue component.The vessel was pre-dilated using an in.Pact admiral 6x150 millimeter device and embolic protection was used with a 5 millimeter spider device.When the physician began retracting the sheath via the thumb wheel, a loud click was heard.Instructions for use were followed with issue.A workaround for the thumb wheel malfunction was provided and performed without difficulty, but the cable was found to be detached.The device was safely removed from the patient and the procedure was completed using a new device that was not a medtronic product.No patient complications have been reported as a result of this event.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• 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: 23450738
• Report Number: 2183870-2025-00507
• Device Sequence Number: 8056609
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: (01)00821684051399(17)280318(10)C065828(20)02
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/03/2025

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 Catalogue Number: EVD35-06-150-120
• Device Lot Number: C065828
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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: Male