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 Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Date article was accepted journal article title: mobility of an in-stent plaque protrusion detected with carotid duplex during the carotid artery stenting procedure: a case report kanta tanaka et al med ultrason 2019, vol.21, no.1, 89-92 doi: 10.11152/mu-1539.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports on a patient with symptomatic right carotid artery stenosis the patient was diagnosed as having a cerebral infarction due to atherosclerotic artery-to-artery embolization.Patient had undergone medical treatment with aspirin, clopidogrel, argatroban, and atorvastatin, but left hemiparesis is reported to have worsened because of a recurrent attack on day 2 after admission.Diffusion-weighted imaging (dwi) showed several newly appeared infarcts at the right middle cerebral artery territory.Patient required early intervention due to experiencing recurrent ischemic stroke under the intensive medical therapy.Considering the allergy to iodinated contrast and the unstable nature of the responsible plaque, carotid endarterectomy (cea) was recommended.The patient desired a less invasive treatment, so a carotid duplex-assisted carotid artery stenting (cas) procedure which could be performed with the administration of local anaesthesia was carried out.Fluoroscopic imaging was performed using a biplane flat detector angiography carotid duplex was performed by an experienced sonographer using a 12-mhz linear array transducer.Intravascular ultrasonography was also used.After an 8-fr sheath was inserted through the right femoral artery, 5000 iu of heparin sodium was intravenously administered.An 8-fr curved guiding catheter was fluoroscopically placed into the innominate artery.A non-medtronic embolic protection device was fluoroscopically guided into the right common carotid artery.Under duplex guidance, the embolic protection device crossed the lesion and advanced into the right internal carotid artery (ica).The filter was opened under fluoroscopy in the distal extracranial right ica.Stent size was determined on the basis of the ivus measurement of arterial diameters and lesion length and level.Using carotid duplex monitoring, a protégé rx 9×60-mm stent was positioned and deployed.Following this, ivus revealed a small in-stent plaque protrusion (isp) with no distinct characteristics.The isp was attempted to be observed using extravascular carotid duplex, and the mobile features of the protrusion were disclosed.To prevent distal embolization, stent-in-stent implantation using a non-medtronic 9x30mm stent was performed.No remaining protrusions were observed with either ivus or carotid duplex, and the patient experienced no periprocedural strokes.Carotid duplex performed at 14 days and 6 months after the procedure showed no protrusion or restenosis.

• 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: 8494739
• MDR Text Key: 141311590
• Report Number: 2183870-2019-00166
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 03/26/2019
• 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: 87 YR