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

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Journal article: device profile of the resolute onyx zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy authors: moritz blum, davide cao & roxana mehran journal: expert review of medical devices year: 2020 reference: doi:10. 1080/17434440. 2020. 1736037. There is no established or suspected causal relationship between the device and the death events. Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product. Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device. If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled "device profile of the resolute onyx zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy" was submitted. The aim of the article was to review the resolute onyx device features using pre-clinical evidence and clinical studies which involved patient's being treated with resolute onyx. The review used data from several studies and registries including the bionix trial, onyx one trial, resolute onyx 2mm clinical study, hong kong resolute onyx registry, resolute onyx core trial and the kamir registry. The total of 3076 participants from these studies that had at least one resolute onyx implanted. Clinical outcomes included target lesion failure (tlf); defined as a composite of cardiac death, target vessel mi and target lesion revascularization (tlr); definite and probable stent thrombosis, late lumen loss, chronic total occlusion and in-stent restenosis. Malapposed struts at baseline and 30 days were also reported, with no stent recoil or significant late acquired malapposition indicated. The article also referred to two studies in which resolute integrity coronary drug eluting stents were used, the dutch peers study and the sort out vi study. One year follow-up outcomes for these studies included cardiac death, myocardial infarction and target vessel revascularization (tvr).

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10811092
• MDR Text Key: 219350222
• Report Number: 9612164-2020-04324
• 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

• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/09/2020 Patient Sequence Number: 1