MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; CORONARY DRUG-ELUTING STENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Stenosis (2263); Insufficient Information (4580)

Event Date 01/09/2023

Event Type  Injury  

Event Description

A journal article was submitted for review titled "30-day outcomes of resolute onyx stent for symptomatic intracranial stenosis: a multicenter propensity score¿matched comparison with stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial".The aim of this article was to investigate the 30-day stroke and/or death rate associated with intracranial stent placement for symptomatic intracranial atherosclerotic disease (sicad) using the resolute onyx drug eluting stent (des) and provide a comparison with the results of stenting versus aggressive medical management for preventing recurrent stroke in the intracranial stenosis (sammpris) trial.Propensity score matching was also performed using age, hypertension, lipid disorder, cigarette smoking, and symptomatic target vessel to create a matched group for comparison between resolute onyx group and the sammpris medical management and treatment groups (sammpris percutaneous angioplasty and stenting [s-ptas]).Databases across 8 stroke centers were used to identify adult patients treated with a resolute onyx des for sicad between january 2019 and december 2021.Patients who presented with either recurrent stroke or transient ischemic attack (tia), intracranial stenosis 70% to 99%, and with at least one event on best medical management were included.The primary outcome was 30-days composite of stroke, intracerebral hemorrhage (ich), and/or mortality.Secondary end points included long-term outcomes and in-stent restenosis (isr) rates.Recurrent tia, stroke, and/or death beyond 30 days was employed as a long-term outcome.A total of 132 patients met the inclusion criteria for analysis in the resolute onyx group.The sammpris medical management (s-mm) group comprised 227 patients, and the sammpris percutaneous angioplasty and stenting (s-ptas) arm included 224 patients.The mean pre-procedure severity of stenosis was 81.4% (±11.4%).Stenosis was present in the basilar, intracranial carotid, middle cerebral artery (mca) stem (m1) and vertebral artery.A total of 4 (3.03%) stroke and/or deaths were reported within 30 days in patients treated with resolute onyx des.Two deaths were related to ipsilateral ich.One of the deaths was because of an intraoperative rupture of an unappreciated aneurysm.Two ipsilateral ischemic strokes were observed.No access site complications were reported.The mean residual stenosis was 6.5%.Ninety-seven patients had clinical follow-up beyond 30 days.The mean follow-up time was 7.4 months.Only 28 patients had angiographic follow-up at 7.5 months.Fifty patients had radiographic evaluation performed by either computed tomography or magnetic resonance angiography in the follow-up period.Two patients had recurrent stroke and four patients had tias during the follow-up period.Recurrent strokes were either in the treated territory (n = 1) or ipsilateral (n = 1) and occurred within 6 months.Four out of those had isr on follow-up angiogram and all 4 patients were retreated with angioplasty.There were 4 deaths in the follow-up period, all believed to be unrelated to stenting procedure.One patient died after a cardiac arrest event, 1 patient died from metastatic cancer, 1 patient died from complications of pre-existing end stage renal disease, and another patient died of unknown etiology.

Manufacturer Narrative

Title: 30-day outcomes of resolute onyx stent for symptomatic intracranial stenosis: a multicenter propensity score¿matched comparison with stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.Authors: siddiq, farhan; nunna, ravi s.; beall, jonathan m.; khan, inamullah; khan, musharaf; tekle, wondwossen g.; ezzeldin, mohamad; tanweer, omar; burkhardt, jan-karl journal name: neurosurgery year: 2023 reference: doi: 10.1227/neu.0000000000002338.Average age: majority gender: date of publication patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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.

Manufacturer Narrative

Annex d code.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: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16654709
• MDR Text Key: 312409336
• Report Number: 9612164-2023-01389
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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: 03/13/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/18/2023
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic