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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
Catalog Number RONYX22508UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that 8 resolute onyx rx coronary drug eluting stents were implanted in the rca and that 3 retracted.It is reported that a serious injury occurred.No further details are available.
 
Additional Manufacturer Narrative
Medwatch report: mw5082763.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE ONYX RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key8417440
Report Number9612164-2019-00867
Device Sequence Number19321463
Product Code NIQ
UDI-Device Identifier00643169556690
UDI-Public00643169556690
Combination Product (Y/N)N
PMA/510(K) Number
P160043
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 03/13/2019
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
Operator of Device Health Professional
Device Expiration Date03/10/2019
Device Catalogue NumberRONYX22508UX
Device Lot Number0008530925
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/14/2019
Supplement Date Received by Manufacturer02/14/2019
Initial Report FDA Received Date03/13/2019
Supplement Report FDA Received Date03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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