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

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Stenosis (2263); Injury (2348)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: long-term clinical outcomes of isolated ostial left anterior descending disease treatment: ostial stenting versus left main cross-over stenting authors: gianluca rigatelli, marco zuin, enrico baracca, et.Al.Journal: cardiovascular revascularization medicine year: 2019 reference: https://doi.Org/10.1016/j.Carrev.2019.01.030.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.Date of publication procedural images were provided in the article however they do not refer to a resolute onyx stent device and so do not confirm any of the adverse events reported for the resolute onyx device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted.The aim of the study was to compare the long term clinical outcomes of two stenting techniques, ostial stenting versus left main cross-over stenting, used in the treatment of isolated ostial left anterior descending disease.Resolute integrity and resolute onyx rx coronary drug eluting stents were among those implanted in the patients.Clinical outcomes reported in the study population included cardiac death, myocardial infarction, stroke, tvr (target vessel revascularisation), in-stent restenosis, stent thrombosis and abrupt vessel occlusion.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9675356
• MDR Text Key: 178005658
• Report Number: 9612164-2020-00584
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/06/2020
• 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: 73 YR