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 Stroke/CVA (1770); Embolism (1829); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

Article title: carotid artery stenting investigation of plaque protrusion incidence and prognosis doi: http://dx.Doi.Org/10.1 016/j.Jcin.2017.01.029.Age/date of birth: mean age of the study population.Sex: gender majority of the study population.

Event Description

This study sought to clarify the incidence and prognosis of pp in carotid artery stenting (cas).Pp was defined as plaque seen inside the stent lumen on both digital subtraction angiography and ivus.A total of 354 consecutive carotid atherosclerotic stenoses in 328 patients (285 men, 43 women; age range 51 to 97 years [mean age 73.6 years]; 158 symptomatic cases; stenosis rate, 50% to 99% [mean 81.0%]) who underwent cas under ivus between october 2007 and march 2016 were retrospectively analyzed.Cas was performed by standard techniques using an epd and conservative post-dilatation using a percutaneous transluminal angioplasty balloon.Medtronic devices used in procedures were mo.Ma ultra, spider, percusurge (guardwire) and protege.Eleven (11) patient strokes were reported.Ipsilateral ischemic stroke occurred within 30 postoperative days in 10 cases, of which 1 was a major stroke.A tia occurred in 9 cases.In most cases, stroke symptoms were observed immediately post-dilatation.In 2 cases, a tia occurred on day 5 and day 7 after cas.Two (2) myocardial infarctions occurred.This study confirmed that the risk factor of pp was associated with unstable plaque.Based on this finding, distal embolism may have occurred because of soft plaque.Placement of open stents with a high radial force may have led to disintegration of soft, unstable plaque, causing pp.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6689556
• MDR Text Key: 79232843
• Report Number: 2183870-2017-00291
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: 06/07/2017
• 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): Hospitalization
• Patient Age: 74 YR