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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 RONYX22512UX
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/15/2019
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
A resolute onyx rx coronary drug eluting stent was intended to be used to treat a lesion.It was reported that the stent dislodged from the delivery system.The stent was introduced twice.It was first removed due to failure to cross the lesion.Then it dislodged from the delivery system.A snare kit was used to retrieve the stent.
 
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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 Key9295678
Report Number9612164-2019-04697
Device Sequence Number19426504
Product Code NIQ
UDI-Device Identifier00643169556706
UDI-Public00643169556706
Combination Product (Y/N)N
Initial Reporter StateAL
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
Report Date (Section B) 11/08/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date10/22/2020
Device Catalogue NumberRONYX22512UX
Device Lot Number0009396801
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/08/2019
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 Required Intervention;
Patient Age68 YR
Patient Weight91
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