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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

Siddiq f, nunna rs, beall jm, khan i, khan m, tekle wg, ezzeldin m, tanweer o, burkhardt jk, jabbour pm, tjoumakaris si, herial na, siddiqui ah, grandhi r, martin rl, qureshi ai, hassan ae."thirty-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." neurosurgery, no.6, 2023, doi:10.1227/neu.0000000000002338.Pmid: 36700730.Pages: 1155-1162.A2: average age a3: majority gender b3: 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.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.

Event Description

A journal article was submitted for review titled "thirty-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".In this study, data from 8 high-volume neuro endovascular centers was combined in order to compare the 30-day stroke and/or death rate associated with intracranial stent placement for symptomatic intracranial atherosclerotic disease (sicad) using the resolute onyx zotarolimus-eluting stent, and provide a comparison with the results of stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis (sammpris) trial.A total of 132 patients were included in the study.Only 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 symptomatic arteries included the basilar artery (n=8), the intracranial carotid (n=42), the middle cerebral artery stem (mca) (m1) (n=38) and the vertebral (n=44).The primary end point was a composite of 30-day stroke, intracerebral hemorrhage (ich), and/or death.Secondary end points included long-term outcomes and in stent restenosis (isr) rates.Recurrent transient ischemic attack (tia), stroke, and/or death beyond 30 days were employed as a long term outcome.A total of 4 stroke and/or deaths were reported within 30 days in patients treated the resolute onyx stent.Two deaths were related to ipsilateral ich (one because of intraoperative rupture of unappreciated aneurysm), and 2 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.Mean follow-up 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.The 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

Additional information: 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.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: 17258267
• MDR Text Key: 319049418
• Report Number: 9612164-2023-02987
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• 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 Age: 64 YR
• Patient Sex: Male