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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 RONYX27512UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Stroke/CVA (1770)
Date of Event 11/12/2017
Type of Reportable Event Serious Injury
Event or Problem Description
During the index procedure resolute onyx des were used to treat the proximal, middle and distal rca and the right posterior descending lateral ((b)(6) 2017).Approximately 5 months post index procedure the patient suffered an acute cva ((b)(6) 2017).
 
Additional Manufacturer Narrative
Investigator assessed that the previously reported stroke event is not related to the study device but possibly related to the antiplatelet.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 Key7166980
Report Number9612164-2018-00024
Device Sequence Number11091932
Product Code NIQ
UDI-Device Identifier00643169556881
UDI-Public00643169556881
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P160043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/30/2018
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 Date01/17/2019
Device Catalogue NumberRONYX27512UX
Device Lot Number0008453537
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/19/2017
Supplement Date Received by Manufacturer01/24/2018
Initial Report FDA Received Date01/05/2018
Supplement Report FDA Received Date01/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening;
Patient Age60 YR
Patient Weight125
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