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 11/27/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician attempted to use a protégé rx self-expanding stent during treatment of a calcified lesion in the patient¿s mid common carotid artery.Moderate vessel tortuosity and calcification are reported.Lesion exhibited 90% stenosis.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.Embolic protection was not used.The lesion was not pre-dilated.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.Deployment issues are reported.The lock-pin was removed at the time of the procedure, but the stent was unable to be deployed.The device was safely removed from patient.Stent struts were visible on removal from patient.8-6x30mm stent was used to compete the procedure.No injury to patient.

Manufacturer Narrative

Device analysis: the device was returned with the touhy-borst tight.The device was returned with the stent fully enclosed.The stent was confirmed as 40mm and with biologics in the shaft.The device was flushed.A 0.014¿ guidewire was loaded, and the device was loaded into a deployment fixture.The stent could not be deployed with a maximum peak force of 5.85lbs.A visual inspection of the stent found that there are 3 radiopaque markers on the proximal end of the stent (retainer end) and 6 radiopaque markers on the distal end indicating that the stent was loaded in the correct orientation.The customer¿s report that the stent could not be deployed can be confirmed.During functional testing the stent could not be deployed with a maximum peak force of 5.85lbs (greater than 3.00lbs as per (b)(4).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: 13023835
• MDR Text Key: 288382791
• Report Number: 2183870-2021-00461
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P060001
• 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,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B237002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 07/20/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male