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

Catalog Number	EVD35-07-100-150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
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
Physician was attempting to use a everflex entrust 7x100x150 in the superficial femoral artery, proximal mid distal peripheral artery(s).Calcified and plaque lesion, minimal tortuosity and moderate calcification.70-90 % lesion stenosis, lesion length 200mm and a rtery/vein diameter 5-6mm.A 5fr sheath with a 035 benson gw was used.Ifu was followed.Embolic protection was not used, the vessel was pre-dilated with bard dilation device.The device did not pass through a previously deployed stent and no resistance was encoun tered when advancing the device.The thumbscrew/lock-pin was checked for securement prior to procedure.It was reported that there was deployment issues, the stent pre-deployment (on way to target site) in the patient.Partial deployment, 75% of the stent deployed and the distal part of the stent got stuck in the inner sheath and would not release the stent.Physician ended up using force and pulled the stent catheter out through the 5fr sheath.The tip of the stent sheared off.Attempts were made to remove the stent but remains in the patient.No deformation noted to the deployed stent and the delivery system was safely removed.No other actions taken as a result of the pre-deployment, no injury/intervention associated with this event and no vessel damage.A new device, evd35-07-100-150 was used to complete the procedure.
Additional Manufacturer Narrative
Product analysis the device was returned with the red safety tab out of the device and no stent in the device the device was identified from the strain relief,.The silver outer sheath was observed to be pulled down from under the stain relief at approx.20.5cm and the blue outer sheath was located at 37.5cm from the strain relief, two kinks were observed along the gold outer sheath, at approx.39.5cm and 53cm from the distal end of the device, the handle was opened and the pull wire was noted to have come away from 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.

• 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: 21934446
• Report Number: 2183870-2025-00222
• Device Sequence Number: 20184565
• Product Code: NIP
• UDI-Device Identifier: 00821684051696
• UDI-Public: 00821684051696
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EVD35-07-100-150
• Device Lot Number: B748574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Sex: Unknown