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

Device Problem Fracture (1260)

Patient Problems Aneurysm (1708); Myocardial Infarction (1969); Respiratory Failure (2484); Vascular Dissection (3160)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: a stent fracture associated with giant coronary aneurysm authors: hsiu-yu fang, wei-chieh lee, feng-yu kuo journal: the international journal of cardiovascular imaging year: 2020 reference: doi.Org/10.1007/s10554-019-01702-w.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 - a stent fracture associated with giant coronary aneurysm - was submitted for review.This is a case study of a patient who had a 3.5 ¿ 26 mm medtronic resolute onyx coronary drug eluting stent (des) implanted in the proximal right coronary artery (rca), for a non-st segment myocardial infarction (nstemi).One year post stent implant, the patient developed another nstemi and respiratory failure and a coronary angiography (cag) was performed.The cag showed stent fracture and a giant coronary artery aneurysm (caa) at the proximal rca.Optical coherence tomography (oct) confirmed the giant caa, and some dissected flaps.A percutaneous coronary intervention (pci) was performed and a non-medtronic bare metal stent was implanted to the area.Post pci, oct showed sealed dissection flaps, but the residual caa still existed.The patient continued on dual-antiplatelet therapy and no adverse events happened at a one-year follow-up.

Manufacturer Narrative

Additional information: procedural images in the article provided the basis of the analysis.In the images stent fracture and one giant coronary aneurysm were noted at proximal rca.Optical coherence tomography (oct) showed the giant caa and some dissected flaps.After deployment of one non-medtronic bare-metal stent and post dilatation, coronary angiogram still showed the residual giant caa.Oct showed sealed dissection flaps, but the residual caa still existed.The images confirm the stent fracture/deformation, dissection and the aneurysm reported.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: 12023071
• MDR Text Key: 261091285
• Report Number: 9612164-2021-02375
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR