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 Hemorrhagic Stroke (4417); Ischemia Stroke (4418)

Event Date 06/09/2022

Event Type  Injury  

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.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.

Event Description

Carotid endarterectomy (cea) and carotid artery stenting (cas) are recommended based on certain risk factors.The volume of an institution¿s treatment experience may be associated with good clinical outcomes.There is a dilemma between the treatment strategy based on risk factors and the experience volume.This study investigates the clinical outcomes of cas performed at institutions that selected the treatment strategy based on risk factors and those that performed cas at the first-line treatment.A total of 239 and 302 patients underwent cas at the cea/cas institutions.Embolic protection devices including spider fx and mo.Ma ultra were used in all patients.The embolic protection technique was classified as single and double protection.Single protection was defined as only distal protection.Double protection was defined as proximal as well as distal protection, such as that achieved with the mo.Ma ultra and a balloon-guiding catheter.Protege stents and non-medtronic stents were used for stenting.For each treatment strategy, the ischemic and hemorrhagic complications were routinely evaluated using magnetic resonance imaging or computed tomography within 72 hours of the procedure.Approximately 7 days before cas, patients received oral dual antiplatelet therapy consisting of: aspirin 100 mg daily, clopidogrel 1 50 mg daily, and cilostazol 100 mg twice daily.Cas was performed under local anesthesia using the transfemoral approach.Transcarotid artery revascularization (tcar) was not performed during this period.A heparin bolus of 80 u/kg was given before the interventio nal procedure with a targeted activated clotting time of 250 to 300 s.Perioperative dual antiplatelet therapy for cas was continued during the perioperative period in this study.The incidence of hypertension in the cas-first institutions was significantly higher than that in the cea/cas institutions (81.5% vs 69.0%; p<(><<)>0.01).No other differences were observed between the 2 institution groups (table 3).The proportions of patients with restenosis, contralateral occlusion, tortuous or elongated vessels, thoracic or abdominal aortic.Aneurysm, receiving postradiation therapy, or were at high risk for general anesthesia were significantly higher in the cea/cas institutions than in the cas-first institutions.Ischemic stroke occurred within 30 days of the intervention in 12 patients (5.0%) in the cea/cas institutions and 7 patients (2.3%) in the cas-first institutions; there was no significant difference in the ischemic stroke rate between the 2 institution groups (p=0.09).No significant differences were observed between the 2 institution groups in the rates of major ischemic stroke (0.8% vs 1.3%; p=0.59),hemorrhagic stroke (0.4% vs 0.3%; p=0.87), and death(0.0% vs 0.7%; p=0.21).Myocardial infarction did not occur in either of the institution groups.2 deaths were reported in the cas-first institutions group.It was found that cas-specific treatment strategies for cas can achieve the same level of outcomes as the treatment strategy based on risk factors.The cas performed based on risk factors in cea/cas institutions and the treatment of more than 30 patients/year/institution in cas-first institutions were associated with good clinical outcomes.

Manufacturer Narrative

Literature title comparison of the clinical outcome of carotid artery stenting between institutions with a treatment strategy based on risk factors and those with first-line treatment journal of endovascular therapy 2023, vol.30(5) 746¿755 doi: 10.1177/15266028221102654 a3 average 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.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: 18109323
• MDR Text Key: 327884529
• Report Number: 2183870-2023-00402
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• 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: 10/17/2023
• 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 Sex: Male