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 Cardiac Arrest (1762); Stroke/CVA (1770); Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 08/10/2022

Event Type  Injury  

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.

Event Description

Objective:to investigate the correlation between annular plaque calcification in the carotid sinus and perioperative hemodynamic dis order (hd) in carotid angioplasty and stenting (cas).Methods: the clinical data of 49 patients undergoing cas due to narrowing of the carotid sinus were retrospectively analyzed.All patients had preoperative carotid computed tomography angiography (cta) and were divided into hd and non-hd groups based on the occurrence of hd in the perioperative period of cas.Hd was defined as persistent bradycardia (heart rate <(><<)> 60 beats per min) or persistent hypotension (systolic blood pressure <(><<)> 90 mmhg) in the perioperative period and lasting for at least 1 h.The baseline data, including the degree of carotid artery stenosis, plaque length, plaque thickness, calcified plaque morphologies (i.E., plaque circumferential angle: <(><<)> 90° defined as dotted calcification; 90° 180° defined as arcuate calcification; > 180° defined as annular calcification), contralateral carotid artery conditions, balloon diameter, and stent types, were compared between the two groups.Binary logistic regression was used to analyze the risk factors for the occurrence of hd.Results: among the 49 patients undergoing cas, 14 (28.57%) developed perioperative hd, and 35 did not.Annular calcification was more common in the patients in the hd group than in the non-hd group.No significant differences in the probabilities of dotted and arcuate calcifications were found between the two groups (p > 0.05).The duration of continuous dopamine consumption in the hd group was 9 71 h.The average hospital stay of the hd group (10.14 § 4.17 days) was significantly longer than that of the non-hd group (6.57 § 1.9 days; p <(><<)> 0.001).Patients in the hd group had significantly more pronounced lumen stenosis (p = 0.033) and longer plaque length (p = 0.034) than those in the non-hd group.After adjusting for age and sex, multivariate regression analysis showed that the presence of annular plaque calcification was an independent predictor of hd (odds ratio: 7.68, 95% confidence interval: 1.46 40.37, p = 0.016).Conclusions: the occurrence of annular plaque calcification in the carotid sinus was an independent risk factor for perioperative hd in cas.Preoperative carotid cta assists with the early identification of high-risk patients who may develop hd.Cas was performed by two neurosurgeons, each with 15 years of experience in neuro-intervention.Local anesthesia was performed in each patient through femoral arterial puncture, and was followed by sending an 8f mach 1tm guide catheter (boston scientific, (b)(4) to the common carotid artery for systemic heparinization (70 u/kg).All procedures were performed under the placement of the spiderfx embolic protection device (ev3, (b)(4).Atropine sulfate (100 mg) was intravenously administered before balloon expansion.According to the vascular diameter and degree of stenosis of individual patients, a 4-, 5-, or 6-mm balloon (cordis, (b)(4) was selected for expansion, following pre-expansion with a 3- mm balloon, if needed.No post-expanded balloon was used.Either the prot eg e stent (ev3 inc., in 45 cases, 91.84%) or carotid wallstent (boston scientific, in 4 cases, 8.16%) was used for implantation.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15666102
• MDR Text Key: 302353539
• Report Number: 2183870-2022-00366
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• 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: 72 YR
• Patient Sex: Male