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

Catalog Number	SERB65-10-80-80
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
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
On (b)(6) 2024 physician implanted a protege gps self-expanding stent during treatment of an 80mm lesion in the patients left proximal cephalic subclavian vein.Moderate vessel tortuosity and minimal vessel calcification were reported.Lesion exhibited 70% plus stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, (i.E.Shelf carton, hoop/tray).No issues were noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.No resistance was noted during advancement of the device.On (b)(6) 2024 during device follow up a fracture was noted to the deployed stent.A replacement 10x80x80 medtronic stent was placed over the protégé stent.No patient injury reported.
Additional Manufacturer Narrative
Image analysis the customer returned one image for evaluation.Image 1: this image depicts what appears to be the patients left proximal cephalic subclavian vein.The stent can be visualised in the image and a fracture of the stent can be observed.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: 19989438
• Report Number: 2183870-2024-00254
• Device Sequence Number: 18278708
• Product Code: FGE
• UDI-Device Identifier: 00643169729094
• UDI-Public: 00643169729094
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K033314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/21/2024

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: SERB65-10-80-80
• Device Lot Number: B690541
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 02/09/2024
• 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: Required Intervention
• Patient Sex: Male