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

Catalog Number	SERB65-10-40-120
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a protege gps self-expanding stent with a 45 cm 6 fr non-medtronic sheath during treatment of a 30 mm calcified lesion in the patients right distal common iliac artery.Severe vessel calcification was reported.Lesion exhibited 70% stenosis.Artery diameter reported as 10 mm.There were abnormalities reported in relation to anatomy.Narrowing was at the distal end of a very short common iliac with calcification and severe narrowing of the right internal iliac artery.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues 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.The vessel was pre-dilated.The vessel was not post-dilated.The device was not passed through a previously deployed stent.Moderate resistance was encountered when advancing the device.Excessive force was not used.It was reported the stent deployed prematurely inside of the access sheath as the system was being advanced to the lesion site and remained inside the sheath.The stent does not remain in the patient.The device was removed successfully in tandem with delivery system without injury/intervention.The device was safely removed from the patient.Procedure was aborted.No vessel damage reported.No patient injury reported.
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 in a deployed state, with the manifold safety locking pin loosened.The distal end of the device was stuck in an unknown introducer.The device was confirmed from the strain relief.Portion of the introducer was skived back, and the stent could be visualised.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 28mm and 30mm 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 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: 20320197
• Report Number: 2183870-2024-00312
• Device Sequence Number: 20857869
• Product Code: FGE
• UDI-Device Identifier: 00643169729049
• UDI-Public: 00643169729049
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K033314
• 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): 12/12/2024

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: 08/08/2025
• Device Catalogue Number: SERB65-10-40-120
• Device Lot Number: B428461
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/12/2024
• Date Device Manufactured: 08/09/2022
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG