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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Event Date 11/04/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: fractional flow reserve¿guided pci as compared with coronary bypass surgery authors: william f fear on, frederik m zimmermann, bernard de bruyne, zsolt piroth, albert h m van straten, laszlo szekely, giedrius davidavicius, gintaras kalinauskas, samer mansour, rajesh kharbanda journal: the new england journal of medicine year: 2022 reference: doi: 10. 1056/nejmoa2112299. Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted titled: fractional flow reserve¿guided pci as compared with coronary bypass surgery. The study was a multicenter, international, non-inferiority trial, where patients with three-vessel coronary artery disease were randomly assigned to undergo coronary-artery bypass grafting (cabg) or fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) with current-generation zotarolimus-eluting stents. A total of 1500 patients were randomized with 757 randomly assigned to undergo pci and 743 to undergo cabg. The lesions treated included vessels with chronic total occlusion and bifurcation lesions. Patients treated with pci received either resolute integrity or resolute onyx drug eluting stents. At 1 year follow up the following end points were noted in the pci group: death from any cause, myocardial infarction, stroke, repeat revascularization, barc type 3¿5 bleeding, acute kidney injury, atrial fibrillation or clinically significant arrhythmia, definite stent thrombosis and rehospitalization within 30 days.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13496804
MDR Text Key285323662
Report Number9612164-2022-00537
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
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: 02/09/2022 Patient Sequence Number: 1
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