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 Bradycardia (1751); Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Ischemia Stroke (4418); Restenosis (4576)

Event Date 05/02/2021

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Event date: date of article publication could gender impact on immediate and long-term carotid artery stenting outcome? insight from an italian single center experience annals of vascular surgery (2021) 76:342-350 10.1016/j.Avsg.2021.04.014.If information is provided in the future, a supplemental report will be issued.

Event Description

A retrospective monocentric study was conducted on 568 patients (366 males and 202 females).Carotid stenting was carried out using exclusively self-expanding stents.Cerebral protection devices were used in all cases per operators¿ experience.Protégé self-expanding stent were implanted, and spider fx and mo.Ma embolic protection devices were the medtronic devices used in the study.Procedures were preferentially carried out percutaneously via puncture of the common femoral artery, but brachial access or direct surgical approach to cca were adopted when needed, according to aortic arch and target carotid anatomies.Pre- and post-dilatation were not routinely performed.Atropine (0.5¿1 mg) was given intravenously to most patients just before the post-stenting dilation phase to reduce bradycardia and hypotension potentially associated with carotid dilation.All patients underwent an angiographic examination of the culprit carotid lesion in 2 projections and an angiographic examination of the intracranial circulation in anteroposterior and/or lateral projections.The same angiographic imaging was performed at the end of the procedure to determine whether there was any variation in the intracranial blood flow.During the peri-procedural time (in-hospital stay), there was one death for acute lung failure, no episodes of major stroke and one non-fatal acute myocardial infarction (ami).16 minor stroke and 11 tia were registered.In terms of minor complications, 18 episodes of bradycardia, 9 vascular access complications were registered, defining a fundamentally comparable scenario between the two populations examined.One month follow-up with dus showed good technical results without any episode of external carotid occlusion.On long term results (medium follow-up 57 months) we recorded 32 stroke (8 major strokes, 24 minor strokes) episodes, 24 acute myocardial infarction (ami), 13 restenosis and 223 deaths with a slight majority of women dying on the long term.

• 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 ; EI ; 091708734
• MDR Report Key: 12967300
• MDR Text Key: 286431159
• Report Number: 2183870-2021-00450
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/09/2021
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male