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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problems Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2018
Event Type  malfunction  
Manufacturer Narrative
Previously reported stent malapposition occurred in 11 cases. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Journal article: short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: onyx one-month optical coherence tomography study journal: advances in interventional cardiology, year: 2019, ref: doi. Org/10. 5114/aic. 2019. 86009. Age: average age. Sex: majority gender. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The present optical coherence tomography (oct) study analyzed the coverage rate at 30 days after implantation of resolute onyx zotar olimus-eluting stents in 15 patients who underwent percutaneous coronary intervention. All patients were treated with dual antiplatelet therapy during the entire duration of the study. The resolute onyx stents were implanted in the following locations: the left anterior descending artery, the circumflex artery; the right coronary artery and the left main coronary artery. At 1-month follow-up stent malapposition and in-stent area obstruction by neointima were reported. One patient required bailout stenting with an 2. 5 x 11 mm non medtronic stent to treat distal stent edge vessel dissection. The main finding of this study is that the resolute onyx zes had a very high rate of strut coverage at 30 days.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, 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 Key9489998
MDR Text Key188148247
Report Number9612164-2019-05230
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
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 Received12/27/2019
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: 12/18/2019 Patient Sequence Number: 1
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