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

Catalog Number	PRB35-06-120-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A protege stent was attempted to be implanted in the common iliac artery.The type of lesion being treated, lesion length, % lesion stenosis, degree of tortuosity and calcification were, distal aorta: mild saccular aneurysm, moderately calcified.Right cia: mild to moderate diffuse disease, moderately calcified.Right eia: 80% diffuse disease, severe calcified.Right iia: moderate to severe diffuse disease, moderately calcified.Right cfa: 60-70% diffuse disease, moderately to severely calcified.Right sfa: proximal sfa cto, moderate severe calcification, reconstitutes at the mid sfa with collaterals from the profunda femoris.Distal sfa mild to moderate diffuse disease.The ifu was followed.The lesion was pre-dilated, shockwave.It was reported that the stent could not be deployed.The stent did not pass through a previously deployed stent.No resistance noted during advancement.The lock-pin was removed prior to attempted to deployment.There was a delay of 10 minutes as a result of the product malfunction, no medications or treatment as a result of the 10-minute procedure delay.The stent was not implanted and the device was safely removed from the patient.Stent struts were exposed/visible on removal.A new medtronic stent was used to complete the case.No patient injury was reported and patient status is fine.
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 stent separate to the device, the locking mechanism was loose, and the device was returned in a deployed state.The stent was confirmed as 120mm from the strain relief, a kink was observed on the blue outer shaft at approx.12.5cm from the strain relief the stent was examined, and no abnormality was observed to the stent the distal inner assembly was cut just proximal to the stent retainer to allow further testing.The stainless-steel push rod was observed to be bent, (photo 5).A set of witness marks were noted on the stainless steel hypotube approximately 25mm and 27mm 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.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: 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: 20809346
• Report Number: 2183870-2024-00437
• Device Sequence Number: 15821389
• Product Code: FGE
• UDI-Device Identifier: 00821684059968
• UDI-Public: 00821684059968
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/12/2025

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 Expiration Date: 05/10/2025
• Device Catalogue Number: PRB35-06-120-120
• Device Lot Number: B383049
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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: Unknown