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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 Activation, Positioning or SeparationProblem (2906)
Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Journal article: (b)(6). Doi: (b)(4). Average majority date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled: (b)(6) this was a single-center, retrospective observational study which sought to report clinical outcomes after treatment of aorto-coronary ostial stenoses with additional implantation of a dedicated recoil-resistant non-medtronic bare-metal dynamic renal stent (drs) upon recoil of a contemporary drug-eluting stent. These results were compared with patients who underwent repeated intervention for relevant in-stent-restenosis. It was reported that a resolute onyx coronary drug eluting stent recoiled.
 
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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 Key11782461
MDR Text Key249285463
Report Number9612164-2021-01788
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
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 Received07/27/2021
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

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