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

Catalog Number	EVD35-07-150-120
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of critical limb ischemia with rest pain in the left lower extremity, an everflex entrust 7 x 150 x 120 stent was used to treat a calcified chronic total occlusion in the proximal left superficial femoral artery, with stent placement for dissection.The target vessel diameter was 6 mm, with severe lesion calcification and moderate tortuosity.A hostile aortic bifurcation was reported, with multiple episodes of sheath prolapse during the procedure.The vessel was pre-dilated with a 5 mm x 200 mm sterling balloon, and the instructions for use were followed without issue.After approximately 6 cm of stent deployment, the thumb wheel became difficult to rotate and subsequently locked.Troubleshooting by opening the delivery-system handle was attempted; however, tremendous resistance was encountered while retracting the silver inner sheath.The entire system was attempted to be removed which stretched the stent from the proximal sfa across the sfa and into the distal eia.  a femoral cutdown was needed to remove the stent.The eia and cfa portions were removed but the proximal sfa segment was left behind.This segment was later refined with a covered stent(viabahn).Upon removal, the cook ansel 7 fr, 45 cm sheath had considerable sheath disruption with exposed braiding wires.It was speculated that the sheath condition played a part in the stent deployment difficulties.The device was not safely removed from the patient.The procedure was completed with surgical explantation and adjunctive endovascular repair.
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 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 ; +353(091)708096
• MDR Report Key: 50219833
• Report Number: 2183870-2026-00378
• Device Sequence Number: 13339504
• Product Code: NIP
• UDI-Device Identifier: 00821684051474
• UDI-Public: (01)00821684051474(17)280410(10)C080927(20)02
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 08/12/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EVD35-07-150-120
• Device Lot Number: C080927
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 04/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male