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

Catalog Number	EVD35-07-020-120
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
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 an everflex entrust self-expanding stent along with a 6fr non-medtronic sheath and a 0.035 non-medtronic guidewire during treatment of 10mm plaque lesion in the patients right mid common iliac artery.Minimal vessel tortuosity and moderate vessel calcification are reported.Artery diameter reported as 7mm.Lesion exhibited 75% stenosis.There were no abnormalities reported in relation to anatomy.Embolic protection was not used.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.The thumbscrew/lock-pin was checked for securement prior to procedure.The lesion was not pre or post dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Pre-deployment on the way to target site was reported.The stent remains in the patient and no attempts were made to remove stent.Deformation was noted to the deployed stent.One distal marker of the four looks to be bent back.The delivery system was safely removed from patient.No actions taken as a result of the pre-deployment.No vessel damage reported.Stent placed, just about at lesion, but lesion opened and procedure was completed.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the device was returned with the red safety lock pin in place, the strain relief was confirmed as 20mm no stent was returned with the device and the stent pusher was observed in the device at approx.20mm.The red safety lock pin was removed, and the deployment wheel was moved in the direction of the arrow, it was advanced until the stent pusher was visible, biologics were also visible on the stent pusher 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 STANDARD
• 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: 18931759
• Report Number: 2183870-2024-00089
• Device Sequence Number: 11907141
• Product Code: NIP
• UDI-Device Identifier: 00821684051412
• UDI-Public: 00821684051412
• 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: 2024
• 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): 04/26/2024

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 Expiration Date: 05/22/2026
• Device Catalogue Number: EVD35-07-020-120
• Device Lot Number: B568520
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 95 KG