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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Original article evaluation of the association between silent ischemic lesions and stent design in carotid stenting applications https://doi.Org/10.1590/1806-9282.20221437 a2 average age a3 majority gender b3 date of publication 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.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.

Event Description

Medtronic received a journal article titled 'evaluation of the association between silent ischemic lesions and stent design in carotid stenting applications'.The article reports a study that aimed to evaluate the association between carotid stent design and silent ischemic lesion development.The files of the patients who underwent carotid stenting between january 2020 and april 2022 were scanned.Patients with diffusion mr images taken within the postoperative 24 h were included in the study, while those undergoing acute stent placement were excluded.The patients were divided into two groups: those with open-cell stents and those with closed-cell stents.Open-cell stents used were protégé (medtronic and closed-cell stents were non-medtronic stents.A total of 65 patients, including 39 patients undergoing open-cell stenting and 26 patients undergoing closed-cell stenting, were included in the study.New ischemic lesions were detected in 29 (74.4%) patients in the open-cell stent group and 10 (38.4%) patients in the closed-cell stentgroup and were significantly higher in the open-cell group.There was no significant difference between the two groups in terms of major and minor ischemic events and stent restenosis at the 3-month follow-up.At 3 month follow up the following outcomes were reported for the open-cell group; stent thrombosis (n=1), minor ischemic stroke (n=2), major ischemic stroke n=2), macce (n=2) and death (n=1).

• 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: 17570599
• MDR Text Key: 321406191
• Report Number: 2183870-2023-00295
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• 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 Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male