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

Catalog Number	PRB35-05-080-120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to implant a protege everflex stent with a 035 guidewire for the treatment of a soft tissue lesion in the patients left mid arteriovenous fistula.Severe tortuosity was reported.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).The ifu (instruction for use) was followed during preparation, procedure, post-procedure.There were no issues noted when removing the device from the hoop/tray.Embolic protection was not used.The vessel was not post-dilated.The device did not pass through a previously deployed stent.Moderate resistance was encountered when advancing the device.It was reported that the markerband dislodged during use in the patient.The stent was deployed in the target location and remains in the patient.There was no deformation noted to the deployed stent.The patient was taken to surgery for removal of foreign body.The device was safely removed from the patient.The procedure was aborted.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 returned with the locking pin loose.The size indicated on the strain relief was 5 x 80mm.The inner subassembly and distal tip were missing from the returned device.The stent was deployed on the returned device.The distal and proximal grips returned pushed together.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 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: 20278597
• Report Number: 2183870-2024-00311
• Device Sequence Number: 7563825
• Product Code: FGE
• UDI-Device Identifier: 00821684068588
• UDI-Public: 00821684068588
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• 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): 12/09/2024

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: PRB35-05-080-120
• Device Lot Number: B734069
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/09/2024
• Date Device Manufactured: 05/17/2024
• 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 Age: 69 YR
• Patient Sex: Male