MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number	PRB35-06-150-120
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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 the deployment of the stent prb35-06-150-120 protege ef v10 in the right superficial femoral artery, mid-location, there were difficulties noted.The distal end (clear segment) was not attached.The stent did not deploy correctly and was dragged and elongated before finally releasing.The lesion length was 130 millimeters.A 6fr non-medtronic sheath was used.The vessel was pre-dilated.The delivery system was safely removed from the patient.The stent remains implanted in the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the distal end (clear segment) was not attached refers to the lear part where pin/pull is and was noted when stent did not detach while deploying.The distal end (clear segment) does not remain in the patient, it does not enter the body.Stent placement was not adjusted after initial flowering of stent.No action was taken as a result of the stent elongation, the tent was approximately 20-30 mm longer than it should have been.The device was deployed in the target area and the procedure was completed normally without issue.Product analysis the device was returned with the lock pin manifold broken and the stent partially deployed, the device was identified from the strain relief, the crown of the stent was exposed, a visual inspection of the device found that the lock pin manifold was broken, the stent was deployed manually by holding the lock pin manifold together, the stent was examined, and no abnormality was noted, the distal inner assembly was cut just proximal to the stent retainer to allow further testing.A set of witness marks were noted on the stainless steel hypotube approximately 29mm and 31mm from the distal end of the stainless steel hypotube; indicating that the safety locking pin was properly tightened during 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 21866466
• Report Number: 2183870-2025-00209
• Device Sequence Number: 4684367
• Product Code: FGE
• UDI-Device Identifier: 00821684059982
• UDI-Public: 00821684059982
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/15/2025

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: PRB35-06-150-120
• Device Lot Number: C001277
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: Unknown