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

Catalog Number	EVD35-06-100-120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the everflex entrust stent, the device was never implanted due to the physician's observation that the stent catheter tip appeared different than normal under angiography.The stent was not deployed.The device was safely removed from patient.The procedure was intended for the treatment of plaque in the proximal location of the right superficial femoral artery, which exhibited minimal tortuosity and calcification.The artery diameter was noted to be 5 mm.A 55 cm 6 french non-medtronic sheath and a.014 non-medtronic guidewire were used, and the vessel was pre-dilated with a 5 mm nanocross device.The procedure was completed using a new medtronic device, specifically an everflex entrust 6-80.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Product analysis the device was returned with the red lock pin still in situ the device was returned with the 100mm stent fully enclosed, a kink / flattening of the silver-coloured outer sheath was observed and felt during tactile examination, a kink was observed at approx.13.7cm from the strain relief, adjacent to the blue isolation sheath the distal end of the device was examined, and no abnormality was noted a 0.035¿ was loaded through the device and advanced passed the kinks, the red tab was removed and the stent was able to deploy using the deployment wheel the stent was examined, and no abnormality was noted, however biologics were noted and observed on the distal end of the stent.The deployment wheel was further rotated to expose the stent pusher 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.

• 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: 20755734
• Report Number: 2183870-2024-00425
• Device Sequence Number: 9263597
• Product Code: NIP
• UDI-Device Identifier: 00821684051375
• UDI-Public: 00821684051375
• 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
• 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): 01/14/2025

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: EVD35-06-100-120
• Device Lot Number: B750405
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Patient Sex: Male