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

Catalog Number RONYX30038X

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

Patient Problem Rupture (2208)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: covered stents for the percutaneous management of delayed coronary wall rupture following subadventitial rotational atherectomy authors: sophie degrauwe, murat cimci, stéphane mock, stéphane noble, juan f.Iglesias journal: jacc: case reports year: 2020 reference: https://doi.Org/10.1016/j.Jaccas.2020.09.051.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 - covered stents for the percutaneous management of delayed coronary wall rupture following subadventitial rotational atherectomy - was submitted for review.The article is a case-study involving a patient who was admitted to hospital with stable angina.Diagnostic coronary angiogram demonstrated a long heavily calcified mid¿left anterior descending artery (lad) displaying chronic total occlusion (cto), as well as a severe ostial intermediate artery stenosis, and a second marginal branch stenosis.It was agreed to perform multi-vessel staged percutaneous coronary intervention (pci).It was stated that pci of the lad was a complicated procedure due to the cto.Intensive subadventitial plaque modification was performed using a non-medtronic 1.25-mm rotational atherectomy burr, allowing for access to the lesion site.The lesion was pre-dilatated using non-medtronic high pressure non-compliant balloons.Two resolute onyx drug eluting stents, 3.5 mm x 34 mm and 3.0 mm x 38 mm in size, were successfully delivered to the proximal and mid-lad with a good final angiographic result.Due to the complexity of the pci performed, control coronary angiogram was performed at three months and demonstrated two large areas of contrast extravasation at the site of previously implanted stents on proximal and mid-lad, suggesting delayed covered coronary artery wall rupture.Further pci was performed to the proximal and mid-lad with two non-medtronic stents with immediate complete disappearance of the contrast extravasation, confirmed by coronary angiography.Six-month control coronary angiogram demonstrated patent covered stents and no residual contrast leakage.The patient is reported to be alive with no further injury.

Manufacturer Narrative

Additional information: procedural images in the article provided the basis of the analysis and confirm coronary artery wall rupture as reported.Annex d, annex g 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: 11640166
• MDR Text Key: 244599313
• Report Number: 9612164-2021-01390
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX30038X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR