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

Device Problem Positioning Problem (3009)

Patient Problems Air Embolism (1697); Myocardial Infarction (1969)

Event Date 12/14/2020

Event Type  Death  

Manufacturer Narrative

Journal title: cerebral air embolism and vasospasm after carotid revascularization: a case report case rep neurol 2020;12:156¿160 doi: 10.1159/000505722 published online: december 14, 2020.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 case report of a patient with severe carotid artery stenosis who suddenly died due to acute myocardial infarction during carotid artery stenting (cas).The patient had visited the hospital due to frequent episodes of intermittent dizziness and mild unsteadiness.Brain ct showed silent left corona radiata lacunar infarct, and carotid ultrasound revealed left internal carotid artery (ica) 87% diameter stenosis.The patient was admitted for angiography survey.Cerebral angiogram confirmed left ica tight stenosis with ostial stenosis of the bilateral vertebral arteries (right: 60% and left: 65%).The patient underwent cas with a protégé stent placed at the stenotic segment with subsequent post-stent balloon dilation.Immediately after the procedure, sudden collapse and bradycardia were noted.Cardiac resuscitation and intubation were performed, and bedside cardiac echo revealed poor cardiac function.Brain ct was performed, and air was found inside all cisterns and sulci.Under the suspicion of large acute myocardial infarction, the patient expired 4 h after the stenting procedure.On retrospective review of the cerebral angiograms, vasospasm resulting from stent manipulation was found at the distal cervical ica.No device malfunction reported.From (b)(4) the article reported that due to frequent episodes of intermittent dizziness and mild unsteadiness, patient visited hospital.Brain ct showed silent left corona radiata lacunar infarct, and carotid ultrasound revealed left internal carotid artery (ica) 87% diameter stenosis.Patient was advised to admit for angiography survey to evaluate the feasibility of carotid revascularization.Cerebral angiogram confirmed left ica tight stenosis with ostial stenosis of the bilateral vertebral arteries (right: 60% and left:65%).After admission, the patient was given adequate hydration and dual antiplatelets with aspirin and clopidogrel.Under local anesthesia, an 8f sheath was inserted from the right groin area.A non-medtronic filter wire (boston filter wire ez) with an umbrella was opened at the distal portion to ica stenosis, followed by angioplasty with a 5 × 20 mm non-medtronic balloon (sterling balloon boston scientific) at 8 bar.Then, an 8 × 40 mm protege stent (medtronic) was deployed at the stenotic segment with subsequent post-stent balloon dilation.Immediately after the procedure, sudden collapse and bradycardia were noted.After cardiac resuscitation and intubation, a cardiovascular doctor was urgently consulted, and beside cardiac echo disclosed poor cardiac function.Brain ct was performed, and air was found inside all cisterns and sulci.Under the suspicion of large acute myocardial infarction, the patient expired 4 hours after the stenting procedure.On retrospective review of the cerebral angiograms, vasospasm resulting from stent manipulation was found at the distal cervical ica.

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: 12346835
• MDR Text Key: 267411257
• Report Number: 2183870-2021-00303
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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: 01/26/2022
• 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 Outcome(s): Required Intervention; Death
• Patient Age: 63 YR
• Patient Sex: Male