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

Device Problem Insufficient Information (3190)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Study title epo:020 endovascular treatment of carotid stenosis : 106cases d hwang and c hurh neuroradiology (2015) 57 (suppl 1):s1¿s169 s97.

Event Description

Purpose: ischemic stroke is a major cause of adult disability and the 3rd leading cause of death.Approximately 15-30% of ischemic strokes are caused by obstructive carotid atherosclerosis involving the carotid bifurcation.The purpose of this study is to determine safety, short and mid-term outcomes of cas (carotid artery stenting) during the last 5 years in a single cerebrovascular disease specialized hospital.Methods: between january 2006 and december 2014, 106 successful cas out of 106 attempted procedures in 96 patients were included in this study.The indications for cas were symptomatic carotid-artery stenosis 60% and asymptomatic stenosis of at least 80%.There were 74 men and 22 women and their age range was 50-79 years (mean 71.1).Self expanding stents with cerebral protection devices were used in all cases.Acetylsalicylic acid (100mg/d) and clopidogrel (75mg/d) were applied for at least 4 to 5 days prior to procedure.Weight-adjusted (70u/kg) heparin was used.Atropine (1mg) was given intravenously, if needed, to reduce bradycardia and hypotension potentially associated with carotid dilation.Acetylsalicylic acid (100mg/d) and clopidogrel (75mg/d) was continued for 3 months after the interventional procedure.Mono antiplatelet therapy (aspirin, clopidogrel, or ticlopidine) was continued indefinitely.One hundred six stents (56 protege, 37 precise stent, 12 wallstent, and 2 acculink) and distal filters (94 spider rx, 9 filter-wire, 3 embo-shield) were used.Result: there were one death (huge ich) and 4 minor strokes (3.7%) as peri-procedural complications.Follow-up angiography was done in 78 patients (73.5%) for 6-58 months (mean 17.3), there was only one restenosis (0.9%).Clinical follow-up was done for 94 patients (88.6%) for 6-60 months (mean 32), there were two deaths (1.8%), one major stroke (basilar artery, 21 months), and one minor stroke (cerebellum, 10 months).Conclusion: cas is and effective treatment modality and as safe as cea for carefully selected patients.Judicious selection of the procedure is made on a case-by-case after considering the patient (physiological), lesion, and access (anatomical) factors that increase the risk of cas and cea in that particular patient.

Manufacturer Narrative

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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5752286
• MDR Text Key: 48291775
• Report Number: 2183870-2016-00489
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• 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: 05/29/2016
• 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: 71 YR