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

Catalog Number SEPX-9-60-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Abdominal Distention (2601)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

It was reported that a physician was attempting to use a protégé rx self-expanding stent device to treat a carotid artery - common lesion in a patient.No damage noted to packaging, no issues noted when removing the device from the hoop/tray.Device was prepped as per ifu.It was reported that deployment issues occurred, the device could not be deployed.Resistance was encountered and force was applied.The device could not be deployed, device was then removed, and another device inserted and deployed, the doctor is a high-volume user and could not deploy the stent.Felt too much resistance and did not want to continue.No patient injury reported for this issue.

Manufacturer Narrative

Product analysis the device was returned with the tuohy-borst tightened.The device was returned with approx.1.5mm of the stent exposed from the outside tip of the outer assembly the stent confirmed as 60mm a 20cc water filled syringe was used to flush the device without issue, on both annual spaces and inner lumen a 0.014¿ guidewire was loaded through the guidewire lumen without issue, and the device was loaded into a deployment fixture the stent was deployed, and the fixture reached 2.40lbs a visual inspection of the deployed stent and the distal section of the inner could find no abnormalities and the stent was verified as 60mm 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: 15445840
• MDR Text Key: 306417427
• Report Number: 2183870-2022-00306
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: SEPX-9-60-135
• Device Lot Number: B298629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• 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