MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SEPX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/03/2022

Event Type  malfunction  

Event Description

A physician was attempting to implant a protégé rx self-expanding stent for the treatment of a 54mm plaque lesion with 85% stenosis in the proximal/mid region of the left common carotid artery.The artery diameter was 5.5mm with no tortuosity or calcification.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 4x20 balloon.It was reported that patient had stenosis in ica where the physician tried to deploy the stent but he couldn't as delivery system did not work.Resistance was encountered and force had been applied.The device had passed through a previously deployed stent, no resistance was encountered when advancing the device and no excessive force was used.No intervention was required for removal of the device.The device was safely removed from the patient.Stent struts were not exposed/visible on removal.The lesion was treated with a competitor product.The lock-pin was removed after positioning.There was no patient injury.When the device was returned, it was noted that the stent was exposed.

Manufacturer Narrative

Product analysis the device was returned with the touhy-borst tight.The device was returned with 8mm of stent exposed the stent confirmed as 40mm biologics were observed in the lumen of the outer sheath a 20cc water filled syringe was used to flush the device, the device flushed only by the y connector with biologics observed a 0.014¿ guidewire was loaded through the guidewire lumen and advanced the entire length and exited the guidewire port the device was loaded into a deployment fixture the stent could not be deployed with a maximum peak force of 7.50lbs the undeployed / exposed stent was observed with dried biologics on it 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• 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: 16239485
• MDR Text Key: 308153444
• Report Number: 2183870-2023-00030
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B366215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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