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 Pulmonary Embolism (1498); Bradycardia (1751); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Stenosis (2263)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date journal article title: endovascular treatment for near occlusion of the internal carotid artery 30-day outcome and long-term follow-up k.Akkan et al.Clinical neuroradiology (2018) 28:245-252 © springer-verlag berlin heidelberg 2016 10.1007/s00062-016-0546-8.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: the treatment strategy and the correct incidence of near occlusion (no) of the internal carotid artery (ica) is still controversial.In routine radiological imaging no can easily be misdiagnosed as complete occlusion and there is no consensus on the standard treatment strategy.Purpose to present our perioperative and long-term follow up results of ica no patients treated with carotid artery stenting (cas).Material and methods: patients were treated with spider fx and protégé.Between 2004¿2014 a total of 182 patients with ica no were evaluated for cas.The study included 132 male (72.5 %) and 50 female (27.5 %) patients with a mean age of 70.2 years.For distal protection a spiderfx was used in 140 patients and a protégé in 83 patients.Patients underwent a clinical neurological evaluation and radiological imaging of the carotid arteries before the cas procedure.Of the patients 80 (44 %) were asymptomatic.The median clinical and carotid doppler ultrasound (dus) follow-up period was 64 months (range 18¿124 months).Temporary hemodynamic changes, such as bradycardia in 108 patients, hypotension in 55 patients and asystole in 19 patients occurred during post dilation and were managed with intravenous 1 mg atropine in all cases.Results in 182 patient¿s cas were performed, 4 patients (2.2 %) developed minor stroke, 2 patients (1.1 %) developed myocardial infarction, 7 patients developed restenosis, during the follow up period 21 patients died (12 from vascular causes [8 myocardial infarctions and 4 pulmonary embolism] and 9 from nonvascular diseases).Asymptomatic restenosis was detected in seven patients (3.8 %) in the follow-up period.Conclusion: with sufficient neurological evaluation during pretreatment and posttreatment periods and when the procedure is performed with technologically developed products by an experienced interventional team, cas is beneficial in patients with ica no.

• 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: 8291898
• MDR Text Key: 134567624
• Report Number: 2183870-2019-00045
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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: 01/09/2019
• 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: 70 YR