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

Catalog Number RONYX35022X

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Journal article: primary percutaneous coronary intervention of anomalous origin of a high take-off of right coronary artery arising from ascending aorta with percutaneous cardiopulmonary support in acute myocardial infarction authors: takuya shimizu, ken umetani, miu eguchi journal: clin case rep.Year: 2021 reference: doi.Org/10.1002/ccr3.4230.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - primary percutaneous coronary intervention of anomalous origin of a high take-off of right coronary artery arising from ascending aorta with percutaneous cardiopulmonary support in acute myocardial infarction - was submitted for review.This article describes a rare case of successful percutaneous coronary interventions (pci), thrombus aspiration, and stent placement in the setting of percutaneous cardiopulmonary support (pcps) in a patient with st-elevation myocardial infarction (stemi) and anomalous origin of a very high take-off of right coronary artery (rca) arising from the ascending aorta (aao).The patient arrived to hospital in a state of cardiac arrest with no cardiac output.A non-medtronic (mdt) pcps was inserted via the right femoral artery and left femoral vein and return of spontaneous circulation (rosc) was achieved.An immediate echocardiography revealed severe hypokinesis at the left ventricular inferior regions and moderate hypokinesis at other regions with an ejection fraction of about 20%.Emergent coronary angiography (cag) was performed and revealed severe stenosis of the proximal rca with low cardiac output and low blood flow velocity in the aao.A 6fr amplatz left (al) launcher guide catheter was used to cannulate the rca.A non-mdt guidewire was passed through the stenosis, however, the launcher disengaged easily because of inadequate backup support.A non-mdt guide extension catheter (gec) was inserted to strengthen the backup of the pci system smoothly.Once positioned, the gec clearly revealed 99% stenosis of the proximal rca and massive thrombi of the distal portion of the lesion.Thrombus aspiration was done with a non-mdt device.Post thrombus aspiration with a non-mdt intravascular ultrasound (ivus) showed a large quantity of attenuated plaque at the stenotic portion, small residual thrombus at the distal portion of the lesion, and thin superficial calcification in the extensive regions but not extrinsic compression of the rca.The culprit lesion was then treated with a 3.5 x 22 mm resolute onyx drug-eluting stent.Ivus showed a little malposition at an ecstatic portion and slight tissue protrusion into the stent, but overall there was good stent expansion and the final cag revealed good coronary blood flow and no distal embolization.Pcps, intra aortic balloon pump (iabp), and mechanical ventilation were removed on days 5, 6, and 11, post pci, respectively.Postprocedural complications were notable for difficulty walking due to deconditioning and muscle weakness, but no evidence of hypoxic brain injury was noted.The contrast-enhanced computed tomography on day 13 revealed neither neurologic damage nor systemic embolization.Ejection fraction was improved to 45%.Patient remained stable and was ultimately transferred to another hospital for rehabilitation on day 36.

Manufacturer Narrative

Additional information: both the launcher guide catheter and the resolute onyx stent were inspected before use with no issues noted.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.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12512130
• MDR Text Key: 272670118
• Report Number: 9612164-2021-03650
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX35022X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR