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); Hematoma (1884); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Nerve Damage (1979); Ischemia Stroke (4418); Restenosis (4576); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/07/2022

Event Type  Injury  

Event Description

This study is a single-center retrospective study and included patients who underwent carotid artery stenting (cas) and carotid endarterectomy (cea) as elective surgery between january 2012 and december 2020.The 235 patients included were assigned to the cas and cea groups.Within 30 days postoperatively, no significant differences were noted in myocardial infarction, cerebral infarction, and patient mortality.Cea was preferentially implemented under regional anesthesia (ra) with the awake test.However, if the patient was uncooperative or anxious, and if their carotid artery level was at the 2nd cervical vertebra; the procedure was performed under general anesthesia (ga) with a routine shunting if the patient refused ra.In the ra group, arteriotomy was directly closed except in the patients with a shunt.In the ga with routine shunt group, arteriotomy was closed using path angioplasty of the bovine pericardium.All patients then immediately underwent postoperative computed tomographic angiography of the brain to evaluate the following complications: anastomotic site stenosis, acute thrombosis, vascular spasm, embolism, cerebral edema, and haemorrhage.Neurointerventionists performed cas through the common femoral artery under local anesthesia.The mo.Ma ultra proximal cerebral protection device or spider fx embolic protection device was used in all cases to prevent procedure-related embolic cerebral infarction.As for the carotid stent, a non-medtronic (boston scientific, wallstent) or protégé rx gps was used at the discretion of the operator.After the intervention, the patients were transferred to the neurologic icu for at least a day to strictly monitor their blood pressure (systolic blood pressure 140 mmhg), neurologic deficits, and operative wound complications.For asymptomatic patients, clopidogrel single antiplatelet therapy (sapt) was mainly used, and clopidogrel was maintained for both cas and cea before intervention.In symptomatic patients, dual antiplatelet therapy (dapt) was performed, and in cea, the operation was performed with clopidogrel sapt from 5 days before the operation, and it was maintained after the operation.In cas, the procedure was performed using dapt, and clopidogrel alone was used at discharge.Furthermore, antihypertensive and lipid-lowering therapy were continuously maintained.The stroke that occurred within 30 days after cas in all four patients were procedure-related multiple embolic infarctions and intracranial haemorrhage.Three of the four patients were symptomatic.One of the four patients who underwent cas and developed 30-day postoperative stroke developed ipsilateral procedure-induced stroke.In two patients, bilateral haemorrhagic transformation with procedure induced stroke was observed on magnetic resonance imaging, but no surgical treatment was required.The other patient underwent craniectomy owing to bilateral intraventricular haemorrhage and surrounding intracerebral haemorrhage but died on the 28th postoperative day owing to infection and multiorgan failure.Cerebral infarction (ci) occurred within 30 days of cea in a symptomatic patient.The patient suffered from brain edema with multifocal acute infarction.However, no additional neurologic symptoms other than mild drowsy mentality progressed upon discharge.There were no patients with hyperperfusion syndrome in either group.In the cas group, contras t-induced nephrotoxicity occurred in a patient with atrial fibrillation; stage 4 chronic kidney disease after cas occurred in another case, in which haemodialysis was performed.There were five cases of hematoma at the puncture site, but no special treatment was r equired.In the cea group, one patient with asthma had an asthma attack in the intensive care unit after surgery and underwent reintubation.After steroid intake, the patient improved and was discharged without any special problems.Three patients developed a post operative hematoma, two patients were discharged without special treatment, and one patient used compression and haemostatic agents.However,there were no cases where reoperation was required owing to bleeding.After surgery, there was one case of vagus nerve injury and four cases of hypoglossal nerve injury.All five patients had improved symptoms before discharge and did not develop any disability.There were more cases of reoperation due to restenosis after surgery in the cas group, but there was no statistically significant difference.The 2 patients who developed restenosis after the first cas had a reoccurrence at 13 and 51 months, respectively.One patient underwent further cas owing to severe in-stent restenosis.Another patient had moderate to severe in-stent restenosis.However, he refused additional treatment because his life expectancy was not long owing to the terminal stage of small cell lung cancer.There was one case of death within 30 days after cas.Cas was performed due to cerebral infarction that occurred during treatment due to anastomosis leakage and infection after surgery for oesophageal cancer.The patient died 4 days after cas from septic shock.There were 164 symptomatic patients and 71 asymptomatic patients.In asymptomatic patients, there was only one case of 30-day postoperative ci in the cas group, and no other major complications occurred.There were no 30-day postoperative mi, 30-day postoperative ci, and in-hospital postoperative death in the asymptomatic patient group over 70 years of age.During the follow-up period (34±29 months), ci occurred in three patients of 235 patients after postoperative day 30.There was one case in the cas group and two cases in the cea group, with no significant difference.

Manufacturer Narrative

Journal title: comparing carotid endarterectomy and carotid artery stenting: retrospective single-center analysis cho et al.Comparing cea and cas ann palliat med 2022;11(11):3409-3416 | https://dx.Doi.Org/10.21037/apm-22-797 a2: average age a3: majorty gender b3: date of publication.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17640556
• MDR Text Key: 322147874
• Report Number: 2183870-2023-00308
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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: 08/09/2023
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male