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

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

Title: use of drug-eluting, balloon-expandable resolute onyx coronary stent as a novel treatment strategy for vertebral artery ostial stenosis: case series authors: jaims lim, ammad a baig, alexander o aguirre, justin m cappuzzo, kunal vakharia, kyungduk rho, muhammad waqas, andre monteiro, thomas j fretz, elad i levy, adnan h siddiqui journal name: interventional neuroradiology, year: 2022, reference: doi: 10.1177/15910199221138138 average age, majority gender and 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 "use of drug-eluting, balloon-expandable resolute onyx coronary stent as a novel treatment strategy for vertebral artery ostial stenosis: case series".The aim of this retrospective study was to investigate the safety and effectiveness of treatment of vertebral artery (va) ostial stenosis with the resolute onyx coronary drug eluting stent.A total of 26 patients diagnosed with va ostial stenosis who underwent resolute onyx stenting with/without angioplasty between the 1st of january 2015 and the 1st january 2022 were included in this study.This was considered off label use of this stent.Outcomes were assessed based on new or recurrent stroke, transient ischemic attack (tia) or intracranial hemorrhage (ich).Indications for stenting included stroke in 11 patients and tia in 10 patients.Five patients were asymptomatic, and va ostial stenosis was incidentally identified.The lesions treated had a mean percentage of stenosis of 74.9+/- 13.0% and stenosis were located on the left side in 12 patients and on the right side in 14 patients.Contralateral va artery stenosis was present in 10 patients with a mean stenosis of 85.9+/- 20.1%.The arterial access approaches were radial in 14 patients and femoral in 12 patients.All patients were treated with dual antiplatelet therapy (dapt) preceding the stenting procedure.During the procedure a micro guide catheter and micro guidewire were utilized to navigate across the area of va ostial stenosis.The micro guidewire was then advanced into the mid-distal v2 segment of the va.The microcatheter was then removed and the resolute onyx stent was advanced over the area of stenosis in the va.Adequate overhang of the stent was allowed into the subclavian parent artery.Pre-deployment angioplasty was typically performed.A non-medtronic ostial balloon system was then advanced over the microwire and positioned within the stent.The balloon was inflated to nominal pressure and in-stent angioplasty was then completed.Post-stenting angioplasty was performed if satisfactory opening of the stenosis was not evident on the post-stenting angiographic run.Patients were monitored in the neuro-intensive care unit overnight post procedure.All patients were kept on dapt for at least 3 months post procedure.A single stent was placed in all but two cases.During the procedure, there was one instance of a device malfunction in which there was difficulty deploying the stent.The stent failed to open despite several attempts at deployment.The stent was exchanged for a new one which was successfully deployed without further complications.There was also one instance of an iatrogenic vascular dissection that was managed conservatively and was confirmed to have resolved spontaneously by radiographic follow up.No in-hospital mortality was reported.The mean residual stenosis immediately post stenting was 5.71+/- 8.56%.None of the treated patients had any complications in the periprocedural period.Thirty-day stroke and intracerebral hemorrhage (ich) score rates were calculated for 21 of the 26 patients.None of these patients had a stroke or transient ischemic attack (tia).During the 3 month and 6 months follow up (respectively), 2 of 24 patients developed symptomatic in-stent restenosis which was successfully treated with balloon angioplasty in each case.Two of the patients who had no follow-up post procedure died.One of these patients departed from the hospital against medical device after the procedure and later presented with a catastrophic stroke.The other patient developed an unrelated gangrene of the extremities and subsequent sepsis and died after experiencing a complicated medical course.

• 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: 15995597
• MDR Text Key: 308148155
• Report Number: 9612164-2022-04776
• 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
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 11/25/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White