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 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a protégé rx self-expanding stent during treatment of a plaque lesion in the patient¿s proximal and mid common carotid artery.Slight vessel calcification is reported.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.The device was prepped as per ifu without issue.The thumbscrew/ lock-pin was checked for securement prior to the procedure.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.It is reported the stent could not be deployed.The stent entered the body and may have been exposed within the patient.The device was removed from the patient and was replaced to complete the procedure.No patient injury reported.

Manufacturer Narrative

Device evaluation the device was returned with no evident kinks.The touhy-borst was returned in a closed/tight state.The stent was unexposed and undeployed with a slight angle noted on the distal tip.There was visible evidence of biologics in the device.Functional test: a 0.014¿ guidewire was loaded with ease through the distal tip of the stent delivery system.The guidewire was able to navigate out the proximal wire port with ease.During functional testing the device could not be flushed.The device was soaked in warm water overnight and flushed with tergazyme solution in an attempt to clear the biologics, but this was unsuccessful.The device was loaded into a deployment fixture.The touhy borst valve was opened.The proximal deployment paddle was pinned, and the y-manifold was pulled towards the deployment paddle: the stent would not deploy.The stent would not deploy within the maximum peak force of 3.21lbs.The maximum peak force (3.21lbs), exceeds the product specification for stent deployment of less than or equal to 3lbs.The force rose to 4.60lbs which exceeds the product specification.As the stent was attempting to deploy, the deployment paddle exhibited a bend during the process.The stent and sds inner guidewire lumen assembly were examined; no abnormalities were noted.Image review one image file was returned for analysis: image file shows a protégé rx self-expanding stent contained within a biohazard bag.Product label adhered to outer bag documents device as sepx-8-6-40, item:10, lot no: a97691 and mpxr784987 documentation was present in the image which is consistent with the reported event.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: 11055866
• MDR Text Key: 229359092
• Report Number: 2183870-2020-00451
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A976912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR