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

Model Number PRB35-06-040-080

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

A protege everflex self expanding stent was being used to treat a 20mm soft tissue lesion with 70% stenosis in the mid right tibial/popliteal trunk.There was severe tortuosity and moderate calcification.The artery diameter was 6mm.There were abnormalities reported in relation to anatomy, trans tibial retrograde fashion accessing the anterior tibial, the origin of the at was very torturous having difficulties tracking catheters.A 6fr non medtronic sheath and a non medtronic guidewire were used.No embolic protection was used.The  lesion was pre dilated with an evercross.The device was prepped as per the ifu with no issues identified.Resistance was encountered advancing the device, no excessive force was used.It was reported that the delivery system was difficult to remove following stent deployment. stent catheter was removed applied some force (by pulling it off the wire) in a way that the pin pull came apart remaining on the wire and losing wire access because of that reason.The physician had to regain wire access in order to post dilate the treated area but was able to be deployed but off the target lesion with like 5-7mm distally to the target lesion which after postdilation with a 5x80x135 evercross the angiographic result was satisfactory.The procedure was successfully completed.No patient injury or complications were reported.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 16529846
• MDR Text Key: 311166134
• Report Number: 2183870-2023-00076
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00821684059876
• UDI-Public: 00821684059876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRB35-06-040-080
• Device Catalogue Number: PRB35-06-040-080
• Device Lot Number: B435566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male