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 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Physician intended to use a protégé rx carotid stent system along with a spider fx embolic protection device during treatment of a plaque lesion in the patient¿s mid common carotid artery.Little vessel tortuosity and moderate vessel calcification are reported.Lesion exhibited 60% stenosis.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.The thumbscrew/lock-pin was checked for securement prior to procedure/deployment.The lock pin had been removed prior to deployment.It is reported the stent could not be fully deployed and could not be withdrawn after deployment.Stent struts were exposed/visible on removal but stent was safely removed from patient.A replacement stent of the same model was used and then released successfully to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis the device was returned with the touhy-borst tight.The device was returned with approximately 20mm of the stent exposed the stent was confirmed as 40mm, a 20cc water filled syringe was used to flush the device, the device could by the guidewire port only 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 4.15lbs the stent was deployed from the device using manual force, the stent was confirmed as 40mm, with no abnormalities noted, 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: 16777152
• MDR Text Key: 314049592
• Report Number: 2183870-2023-00134
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B438371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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