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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 RONYX35008UX
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Year valid.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
During the procedure, an attempt was made to use one resolute onyx drug eluting stent to treat a lesion.It was reported that the stent became damaged/defective and a stent dislodgement occurred.No patient injury was reported.
 
Additional Manufacturer Narrative
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 Key7576855
Report Number9612164-2018-01357
Device Sequence Number10821171
Product Code NIQ
UDI-Device Identifier00643169557055
UDI-Public00643169557055
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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 Physician
Type of Report Initial,Followup
Report Date (Section B) 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/29/2019
Device Catalogue NumberRONYX35008UX
Device Lot Number0008556999
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/09/2018
Supplement Date Received by Manufacturer10/30/2018
Initial Report FDA Received Date06/07/2018
Supplement Report FDA Received Date10/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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