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

Catalog Number RONYX25018X

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

Patient Problems Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 11/27/2021

Event Type  Injury  

Event Description

A journal article titled - prolonged sinus arrest due to the obstruction of a sinus node branch after percutaneous coronary intervention of the right coronary artery - was submitted for review.A patient presented to hospital with chest pain on effort.A coronary angiogram (cag) revealed chronic total occlusion of the left circumflex coronary artery (lcx), and 90% stenosis in the right coronary artery (rca), and the distal part of the left anterior descending coronary artery (lad).Percutaneous coronary intervention (pci) was performed on the lcx in which two non-medtronic (mdt) stents were inserted.However, the patient's chest pain was not relieved.A second cag showed no in-stent-stenosis or any de novo lesion in the lad or lcx.Severe diffuse stenosis of the rca was observed, and pci was attempted to treat the lesion.After pre-dilation, intracoronary imaging using intravascular ultrasound (ivus) revealed a large amount of diffuse atherosclerotic plaque lesions with partial calcification and vulnerability.The stenosis in the rca was treated by inserting three medtronic resolute onyx zotarolimus-eluting stents.Immediately after these interventions, the sinusnode (sn) artery originating from the rca proximal to the lesion was occluded, which resulted in sn dysfunction due to ischemia.Significant bradycardia was observed along with low blood pressure, suggesting sinus arrest.Crossing a wire to the occluded sn artery failed.Junctional escape rhythm and hypotension were sustained despite medical intervention.A transvenous temporary pacemaker wasplaced to support this condition.A third cag was performed on the 4th day after pci.The sn artery was still totally occluded.An attempt was made to cross a wire to the occluded sn artery again, but failed and reflow of the occluded sn artery could not be achieved.Heart failure and the hemodynamic and hypoxic states worsened gradually, despite pacing.A permanent dual chamber pacemaker was implanted twenty two days after pci.Heart failure and hypotension improved immediately after the placement of the permanent pacemaker.The patient was discharged in a stable hemodynamic state.

Manufacturer Narrative

Journal article: prolonged sinus arrest due to the obstruction of a sinus node branch after percutaneous coronary intervention of the right coronary artery authors: ruri shimizu, rie aoyama, joji ishikawa, kazumasa harada journal: journal of cardiology cases year: 2022 reference: doi.Org/10.1016/j.Jccase.2021.11.014.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: procedural images/data in the article provided the basis of the analysis.The images confirm the presence of diffuse disease throughout the rca and the occlusion of the sinus node artery.Annex d code added 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.

Manufacturer Narrative

Additional information: it was stated that there was causal relationship between the resolute onyx devices the adverse events (occlusion, ischemia, hypotension, bradycardia, sinus arrest, junctional escape rhythm) reported.Implant date provided (d6a).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: 14773709
• MDR Text Key: 294534674
• Report Number: 9612164-2022-02365
• 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,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX25018X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• 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: 78 YR
• Patient Sex: Female