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); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Date 06/13/2021

Event Type  Injury  

Manufacturer Narrative

Article title: the predictive role of a novel risk index in patients undergoing carotid artery stenting: systemic immune index journal of stroke and cerebrovascular diseases, vol.30, no.9 (september), 2021: 105955.Https://doi.Org/10.1016/j.Jstrokecerebrovasdis.2021.105955.Average age, majority gender, 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 centre retrospective study which evaluated the effect of systemic immune-inflammation index (sii) on in-hospital and long-term outcomes in a large patient population who underwent carotid artery stenting (cas).732 patients were included in the study.Medtronic¿s protégé rx stent was included in the range of devices used during procedures.The protégé rx stent was used in 132 procedures.Both in-hospital and longterm outcomes reported for the population included ipsilateral stroke, major stroke, transient ischemic attack, myocardial infarction, death, and major adverse cardiovascular events (mace) where mace was consisted of stroke, tia, mi and death.The authors conclude that significant prognostic information can be obtained from routine blood test results in patients undergoing cas and that sii values at admission was independently associated with in-hospital and long-term mortality and mace in cas patients.Sii improved the risk prediction of major cardiovascular events than traditional risk factors in patients with carotid artery stenosis who underwent cas.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: 12331213
• MDR Text Key: 266879302
• Report Number: 2183870-2021-00295
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/17/2021
• 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