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); Restenosis (4576)

Event Date 02/21/2023

Event Type  Injury  

Event Description

Medtronic received a journal article reporting 'in-stent restenosis and stented-territory infarction after carotid and vertebrobasilar artery stenting¿.Between september 2013 and may 2021, 363 patients who had undergone 417 stent insertions were included (stenting at more than two arteries: 53 patients) in the study.A total of 324 (77.7%) patients underwent cas and 93 (22.3%) underwent vbs.Stenting procedures was performed by neuro-interventionists who were highly experienced in endovascular treatment.The use of catheters, guidewires, and ballooning dilatation was at the discretion of the neuro-interventionist.Non-medtronic stents were used for intracranial stenting.Protégé rx and other non-medtronic stents were used for extracranial stenting.All patients were followed up with computed tomography angiography (cta) and carotid duplex ultrasonography (cdu) within 48hours after the procedure.After discharge, all patients were followed up with cta and cdu at 1month after the procedure.After that, patients were followed up with cta, cdu, magnetic resonance angiography (mra), or dsa examination at 6months after the procedure at the discretion of the stroke neurologist.Thereafter, follow-up neuroimaging was performed every 12 months.The main outcomes were in-stent restenosis and stented-territory infarction.Restenosis higher than 50% of the residual stenosis just after stent insertion at any period during follow-up was considered as in-stent restenosis, regardless of the neuroimaging modality used.Stented-territory infarction was defined as stented-territory ischemic stroke on diffusion-weighted imaging or transient ischemic attack (tia), associated with the stented artery.For clinical outcomes, in-stent restenosis was observed in 34 (8.2%) stent insertion cases and stented-territory infarction was observed in 56 (13.4%) stent insertion cases during 3 years of follow-up.

Manufacturer Narrative

Ryu et al., 'in-stent restenosis and stented-territory infarction after carotid and vertebrobasilar artery stenting', bmc neurology (2023) 23:79 ref: https://doi.Org/10.1186/s12883-023-03110-z.A2: average age, a3: majority sex.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: 17296372
• MDR Text Key: 318972398
• Report Number: 2183870-2023-00254
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2023
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Male