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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a protege rx self-expanding stent along with a 6mm spider fx embolic protection during procedure to treat a little calcified plaque lesion in the left mid common carotid artery with 70% stenosis.The vessel was little tortuous.The vessel diameter and lesion length are 6mm and 30mm respectively.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.Deployment issue occurred.It was reported that the physician was unable to deploy the stent.There was no resistance encountered during delivery to lesion.The device did not pass through a previously deployed stent.The thumbscrew/lock-pin were checked for securement prior to procedure.The lock-pin was removed when the stent was ready to be deployed after reaching the lesion and positioning.The lesion was not pre dilated.Stent struts were partially exposed during deployment attempt.A stent of the same model was replaced with to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Device evaluation visual inspection: the protégé rx was removed from the pouch and inspected.The tuohy-borst valve was loosened.A visual inspection showed the 4cm stent remained loaded the catheter shaft.No portion of the stent was exposed outside of the deployment system.Functional testing: a 0.014¿ guidewire from the lab could not be front of back loaded due to encountered resistance.The protégé rx was loaded the deployment apparatus from within the lab.3.44 of force was applied to the deployment grip, but the stent showed no signs of deployment.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
• MDR Report Key: 10799463
• MDR Text Key: 215280532
• Report Number: 2183870-2020-00364
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A934056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 60