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 Infarction, Cerebral (1771); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: mean age of patient cohort.Sex: 68.7% of patient cohort was male.Date of event: literature article published date long-term results of tapered stents in endovascular treatment of carotid stenosis ann vasc surg 2017; 45: 79¿84 http://dx.Doi.Org/10.1016/j.Avsg.2017.06.If information is provided in the future, a supplemental report will be issued.

Event Description

The journal article explores a study aiming to investigate the impact of stent configuration (tapered stents vs straight stents) on perioperative and long-term results in endovascular treatment of carotid stenosis.During the study period, 1368 carotid artery stenting (cas) procedures were performed at the facility.The mean age of the patient cohort was 71 years and 940 patients were male (68.7 %).In 485 cases, tapered stents, including protégé and cristallo ideale were used while in 883 cases cylindrical stents including exponent were used.During the follow up period, tia occurred in 39 patients and 20 patients suffered strokes.Cases of restenosis were also recorded.Immediate conversion to carotid endarterectomy with stent removal was necessary in 4 cases for stent occlusion or malposition of the stent.The study concluded that the use of conic stents appears to be associated with similar perioperative results when compared with the straights stents.

• 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: 7115369
• MDR Text Key: 94790160
• Report Number: 2183870-2017-00570
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 11/14/2017
• 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): Required Intervention
• Patient Age: 71 YR