MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

Journal title: estimated glomerular filtration rate as a predictor of restenosis after carotid stenting using first-generation stents doi: 10.1177/00033197211014684.Age: average.Sex: majority gender.Event date: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a single-center retrospective database analysis study which evaluated the impact of the baseline estimated glomerular filtration rate (egfr) on clinical and angiographic outcomes and long-term in-stent restenosis (isr) rates in patients undergoing elective carotid artery stenting (cas) procedures.Medtronic¿s spider fx distal embolic protection device was used when crossing the lesion.Medtronic¿s protégé rx self-expanding stents the endovascular cas procedure.477 cas procedures were evaluated for enrolment in the study.33 patient deaths are reported during the 3-year follow-up period resulting from exclusion from the study.Other reasons for exclusion included patients lost to follow-up.The study population remained at 405, in which 38 protégé rx stents were implanted.Pre-dilation was performed in 40 patients, and post dilation performed in 93.6% pf patients.In-stent restenosis is reported in 44 patients throughout the follow-up period.The overall death rate was reported as 7.5% of the study group over the three years.There is no established or suspected causal relationship between the device(s) and the death events.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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 ; EI ; 091708734
• MDR Report Key: 12486547
• MDR Text Key: 272671739
• Report Number: 2183870-2021-00340
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 01/28/2022
• 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 Age: 68 YR
• Patient Sex: Male