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 Local Reaction (2035); Thrombosis/Thrombus (4440)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: uncommon but imperative cause of repeated acute stent thrombosis: kounis syndrome type iii authors: shiro miura, takehiro yamashita, masaki murata, nicholas g kounis journal: bmj case rep year: 2021 reference: doi:10.1136/bcr-2020- 240704.Date of event: date of publication procedural images in the article showed a coronary artery angiography in which acute stent thrombosis of the left anterior descending coronary artery following stent implantation can be seen.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report entitled - uncommon but imperative cause of repeated acute stent thrombosis: kounis syndrome type iii - was submitted for review.Patient suffered acute coronary syndrome complicated by acute stent thrombosis (st) in the proximal left anterior descending artery (lad) one hour after a 2.5x26mm resolute onyx drug eluting stent was implanted under the guidance of intravascular ultrasound (ivus).One year later the patient presented with symptoms of chest pain during exercise.Coronary angiography (cag) revealed no in-stent restenosis in the lad but critical stenosis in the fourth branch of the posterior descending artery.To treat this stenosis a 2.25x38mm non-medtronic drug eluting stent was implanted.Patient was placed on aspirin and clopidogrel.Ivus was performed.One hour after the final angiogram the patient reported chest tightness and nausea.An ecg revealed significant st-segment elevation in the ii, iii and avf leads.It was suspected that the stemi resulted from an allergic reaction and the kounis syndrome type iii.Emergent cag revealed thrombotic semi-occlusion of the pda stent site.Residual thrombus overlying the stent struts was also noted.Aspiration thrombectomy and subsequent balloon angioplasty with a 3 mm non-compliant balloon were performed, which resulted in an improvement from thrombolysis in myocardial infarction (timi) flow grade 1¿2.The intra -aortic balloon was left in place for 3 days, during which time the timi flow grade in the right coronary artery was 3, as determined via cag.As clopidogrel resistance was suspected it was replaced with prasugrel during the bailout pci procedure.Patient was discharged from hospital on day 12 and had no symptoms at the 3-month follow up.

Manufacturer Narrative

Additional information: annex b, annex c, annex d codes added correction: intervention required ticked (b2).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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12539053
• MDR Text Key: 273534163
• Report Number: 9612164-2021-03709
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 11/18/2021
• 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: 69 YR
• Patient Sex: Female