MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	SERB65-09-40-120
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Death
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported while attempting to deploy the protege gps stent, the catheter became lodged with the stent partially deployed.While trying to completely deploy and detach from the stent, the catheter fractured leaving the distal end of the catheter lodged in the patient.Attempts to remove the retained portion of the catheter from the patient were not successful.
Additional Manufacturer Narrative
Additional information: when the detachment occurred, the distal end of stent was partially across the target lesion.The fracture occurred approx.5 mm from distal tip of catheter.There was patient injury, unclear of the cause of the injury and the patient expired within about 24 hours.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
Image review 31 procedural images were returned the first 16 images show insertion of a guide catheter and guidewire to the right side of the cerebral venous sinus.Images 17 18 show a stent being deployed in the cerebral venous sinus.Image 19 20 show the stent with partial blood flow.Images 21 22 shows a partially deployed stent and the tip of the catheter with snare.Image 23 shows multiple attempts to snare the tip of the catheter with the partially deployed stent along with numerous attempts to snag the stent with manipulation of the guidewire.Images 24 25 show the guidewire through the stent.Image 26 shows the stent pulled proximally in the vein.Images 27 29 show the repositioned stent and catheter tip.Image 30 shows a snare attempt of the stent and detached tip.Image 31 shows a snare attempt and the stent fully deployed with the detached tip still attached to the proximal end.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 GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
• 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: 21218136
• Report Number: 2183870-2025-00040
• Device Sequence Number: 8740540
• Product Code: FGE
• UDI-Device Identifier: 00643169728943
• UDI-Public: 00643169728943
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032580
• 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,Followup,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: SERB65-09-40-120
• Device Lot Number: B664869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/31/2025; 03/26/2025; 03/26/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/06/2025; 04/09/2025; 04/23/2025
• Date Device Manufactured: 12/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 87 KG