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 Stroke/CVA (1770); Myocardial Infarction (1969); Nerve Damage (1979); Transient Ischemic Attack (2109); Blood Loss (2597)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Average age.Majority gender.Event date: date of article publication comparative analysis of carotid artery stenting and carotid endarterectomy in clinical practice journal of stroke & cerebrovascular diseases (2020) 29(5);1-10 10.1016/j.Jstrokecerebrovasdis.2020.1047.If information is provided in the future, a supplemental report will be issued.

Event Description

The objective of the retrospective cohort study was to describe immediate and long-term results of carotid endarterectomy (cea) versus carotid stenting (cas) with embolic protection in patients with severe carotid artery stenosis in clinical practice.The study covered 2132 operations in 2006 patients with 57% of these being carotid endarterectomies (cea) and 43% carotid artery stents (cas).All cas procedures were performed under local anaesthesia.Routine embolic protection and dual antiplatelet therapy were used in all cases.The primary endpoint was any stroke, death or myocardial infarction (mi) during the 30-day period post procedure.No device malfunctions, or intr-operative complications are reported.278 patients were lost to follow-up.Of the cas group, 47.6% of patient¿s were treated with medtronic¿s protégé rx carotid stent system.Embolic protection was used in all cases, with 82.6% of patients being treated with a spider fx embolic protection device, and 7% with a moma cerebral protection device.Within the cas group, during the 30-day follow-up period, the following complications are reported: death, stroke, transient ischemic attack (tias), cranial and cervical nerve injuries, and bleeding.Within the 5-year post-procedural follow-up, complications of death, stroke, myocardial infarction(mi), and transient ischemic attack (tias) are reported.The deaths that occurred during the 5-year follow-up were attributed to myocardial infarction, stroke and oncological causes.

• 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: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10085091
• MDR Text Key: 197998043
• Report Number: 2183870-2020-00150
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• 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: 05/15/2020
• 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 Age: 60 YR