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 Codes	Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the customer returned four fluoroscopic procedural images for evaluation all four images show what appears to be the everflex entrust stent in the patient's superficial femoral artery, in two of the images the stent appears to have elongated.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, difficulty was noted during deployment in a heavily calcified target lesion located in the mid right superficial femoral artery.A 5fr non-medtronic sheath was used.No resistance was met during advancement of the device.The physician reported that the stent felt different during deployment and noted that the guidewire "hung up" when being removed.The vessel was pre-dilated with evercross, non-medtronic 5 x 40, nanocross 4 x 40, and a non-medtronic 6 x 20, and post-dilated with a nanocross 6 x 150.The stent was deployed successfully without injury or intervention, and no patient symptoms, complications, or adverse outcomes were reported.Reviewed images showed stent slightly elongated.
Additional Manufacturer Narrative
Product analysis the device was returned with the red safety tab out of the device and a guidewire was stuck in the device, the device was confirmed from the strain relief, the guidewire was measured and noted as 0.014¿ guidewire, the handle was opened and the pull wire was observed to be detached from the device, and kinks were noted on the gold inner sheath, the customer complaint of ¿the physician reported that the stent felt different during deployment and noted that the guidewire "hung up" when being removed.¿ can be confirmed from the returned 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.

• 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: 22402220
• Report Number: 2183870-2025-00348
• Device Sequence Number: 8353082
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: (01)00821684051399(17)280316(10)C064694(20)02
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/04/2025

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: C064694
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Age: 81 YR
• Patient Sex: Male