MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	PRB35-06-200-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use the protege self expanding stent along with 6fr sheath and non medtronic 0.035" guidewire during procedure to treat moderately calcified lesion in the distal location of the right superficial femoral artery (sfa).The vessel was moderately tortuous with 60% stenosis.The vessel diameter was 6mm and lesion length was 200mm.No embolic protection was used.There was no damage noted to the packaging and no issues noted when removing the device from the hoop/tray.Device was prepped per ifu without any issues.It was reported that the catheter sheared off and detached during delivery through the vessel.A snare was used to remove the detached portion from the patient.The vessel was pre-dilated with a 5mm pre-dilation device.There was no resistance encountered when advancing the device and no excessive force used.The procedure was completed by deploying the stent and it was upon removal that it was noticed that the catheter had sheered off.The sheared portion of the catheter was successfully removed from the patient using a snare.There was no noted resistance during the removal.There was no noted vessel damage to the patient.There were no noted issues with the stent.No patient injury reported.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12360057
• Report Number: 2183870-2021-00310
• Device Sequence Number: 11731025
• Product Code: FGE
• UDI-Device Identifier: 00821684059999
• UDI-Public: 00821684059999
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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 Expiration Date: 09/18/2023
• Device Model Number: PRB35-06-200-120
• Device Catalogue Number: PRB35-06-200-120
• Device Lot Number: B088649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 73