MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-08-150-120
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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
It was reported that during a procedure to treat a chronic total occlusion of the left superficial femoral artery using the stent pr b35-08-150-120 protege ef v10 and stent prb35-07-150-120 protege ef v10, there were deployment issues.The first stent could not be deployed, and the handle broke during the attempted deployment.When a second stent was used, there was difficulty deploying it as well.Both devices were safely removed without exposing any stent struts or requiring intervention for removal.The vessel was pre-dilated with a 4/80 nano device and post-dilated with a 6/120 pacific plus device.No patient symptoms, complications, adverse events, infections, deaths, or irregularities were reported.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis the device was returned in a deployed state with the manifold safety locking pin mechanism loosened and with the stent returned separately, the device was identified as 150mm from the strain relief, the returned stent was confirmed as 150mm, with no abnormalities observed, a 20cc water filled syringe was used to flush the device through both the annual spaces, the device could flush through the two spaces, an in-house 0.035¿ guidewire was used for guidewire loading check, and it was able to advance through the device.The distal inner assembly was cut just proximal to the stent retainer to allow further testing.Witness marks were noted on the stainless steel hypotube approximately 26mm and 28mm from the distal end of the stainless steel hypotube, indicating that the safety locking pin was tightened in manufacturing.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: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 24342945
• Report Number: 2183870-2026-00070
• Device Sequence Number: 9966691
• Product Code: FGE
• UDI-Device Identifier: 00821684060322
• UDI-Public: (01)00821684060322(17)261212(10)B669095
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/07/2026

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: PRB35-08-150-120
• Device Lot Number: B669095
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG