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

Model Number	PRB35-06-150-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a procedure involving a self-expanding stent would not expand or deploy once unsheathed from the catheter.The procedure was conducted on the left superficial femoral artery, proximal, which had a severe calcified lesion with 100% stenosis and a length of 150 millimetres.The artery diameter was 6 millimetres.In relation to the patient¿s anatomy and prior to the procedure, the artery was clotted off with a chronic total occlusion, and a pneumbra and lytic catheter were used overnight the day before.Moderate resistance was encountered when advancing the device.The device was safely removed, and the procedure was completed using a new device.10 minutes delay in surgery due to product malfunction.The patient died on the next day and it is reported that the cause of death was cardiac arrest.
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
Additional information: the cto did not inhibit the deployment/expansion of the first protege.The fielder guidewire was not kinked prior to the delivery of the first protege and the guidewire was exchanged for use with the new device.The new device used was the same size/type medtronic protege ef.It was confirmed confirm that the stent unsheathed without expansion then re-sheathed.Product analysis the device was returned with the lock pin loose, and the blue outer shaft detached from the deployment handle and lock pin, there is approximately 1.5mm of the stent exposed, 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
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
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: 21581656
• Report Number: 2183870-2025-00128
• Device Sequence Number: 12969978
• Product Code: FGE
• UDI-Device Identifier: 00821684059982
• UDI-Public: 00821684059982
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRB35-06-150-120
• Device Catalogue Number: PRB35-06-150-120
• Device Lot Number: B818911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 05/23/2025; 06/05/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/23/2025; 06/06/2025
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 87 KG