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

Catalog Number RONYX35018UX

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

Patient Problems Ischemia (1942); Insufficient Information (4580)

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

Title: successful distal administration of high doses of adenosine and nicardipine using export catheter for treatment of resistant no-reflow in a vein graft, year: 2022, reference: issn:2160-200x/ajcd0141001, author: mohammad reza movahed, journal name: american journal of cardiovascular disease.Date of event is date of publication.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 case study was submitted for review titled: "successful distal administration of high doses of adenosine and nicardipine using export catheter for treatment of resistant no-reflow in a vein graft".A patient with a history of coronary bypass grafting more than 15 years ago presented with substernal chest pain occurring in the last 24 hours to the emergency department.The patients' electrocardiogram (ekg) revealed infero-posterior st-elevation myocardial infarction.The patient was found to have 100% chronic occlusion of the right coronary and acute 100% occlusion of the mid saphenous vein graft (svg) supplying the posterior descending artery.The decision was made to proceed with intervention due to persistent chest pain despite medical therapy.A 6 french multipurpose guide catheter was used for intervention.The patient received aspirin and heparin in the emergency department.A weight-based bolus of bivalirudin was started with continuous intravenous infusion.A non-medtronic (mdt), 0.014-inch wire was advanced across the lesion without any difficulty.Next, a 2.5 × 15 mm euphora balloon was used for pre-dilatation, establishing thrombolysis in myocardial infarction (timi) 3 flow.Due to persistent residual high-grade disease, a 3.5×18 mm resolute onyx drug eluting stent (des) stent was deployed in the lesion at 16 atm.Post stenting, severe no-reflow occurred with recurrent chest pain.Administration of 60 to 100 micrograms of adenosine, and 100 micrograms of nicardipine intracoronary did not show any improvement in the flow.The decision was made to proceed with the distal administration of high doses of adenosine and nicardipine.An export thrombectomy catheter was advanced into the stented area within seconds.100 and 200 micrograms of adenosine and 200 micrograms of nicardipine was administered distally, with immediate normalization of the flow and complete resolution of chest pain.An echocardiogram revealed a normal ejection fraction with very mild basal inferior wall hypokinesia.

• 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: 16032921
• MDR Text Key: 305975825
• Report Number: 9612164-2022-04882
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX35018UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White