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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 RONYX27508UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Stroke/CVA (1770)
Date of Event 11/16/2017
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
During the index procedure two resolute onyx des were implanted in the 1st diagonal.Approximately 4 months post index procedure patient suffered cardiovascular accident (stroke).Event not resolved.Investigator assessed that event is not related to study device and antiplatelet.
 
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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 Key7243370
Report Number9612164-2018-00205
Device Sequence Number18873176
Product Code NIQ
UDI-Device Identifier00643169556874
UDI-Public00643169556874
Combination Product (Y/N)N
Initial Reporter StateMN
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
Report Date (Section B) 02/06/2018
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 Date01/20/2019
Device Catalogue NumberRONYX27508UX
Device Lot Number0008459056
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2018
Initial Report FDA Received Date02/06/2018
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;
Patient Age65 YR
Patient Weight109
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