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); Thrombus (2101)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date optimal platelet function test for in-stent tissue protrusion following carotid artery stenting journal of international medical research (2018) vol.46(5) 1866¿1875 10.1177/0300060518762949.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports on a prospective, observational study which involved 28 patients which were diagnosed with internal carotid artery stenosis and underwent cas and aims to determine the best platelet function test for in-stent tissue protrusion following carotid artery stenting (cas).Of the study population this paper also reports on a (b)(6)-year-old male.The patient¿s pre-operative digital subtraction angiography (dsa) showed 70% stenosis.The procedure was performed under local anaesthesia administered through the femoral artery.A 9f mo.Ma device with two compliant balloons was navigated into the affected vessel; the distal balloon was placed in the external carotid artery, while the proximal balloon was placed in the common carotid artery.A protégé open-cell stent was then deployed.An intraluminal thrombus was detected by oct as a backscattering protrusion into the carotid lumen.In-stent tissue protrusion was also detected by oct.This paper concluded that collagen-induced platelet reactivity was related to in-stent tissue protrusion size following cas.

• 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: 8008460
• MDR Text Key: 125096385
• Report Number: 2183870-2018-00483
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• 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: 10/01/2018
• 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