MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number	RONYX22508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During index procedure, two resolute onyx drug-eluting stents were implanted in the lcx.Approximately 1 month post procedure, stent thrombosis was found in the onyx stents.Investigator assessed that event is probably related to the study device and possibly related to the antiplatelet medication.Patient recovered.
Additional Manufacturer Narrative
The stent thrombosis was treated with stenting and ballooning of the distal lcx.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient received a medication change as treatment for this event.The event is resolved.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The study stent was not occluded; the thrombotic occlusion was reported 5mm distal to the study stent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudication: subacute stent thrombosis, arc definite, related to distal cx.The event was not related to a thrombotic occlusion, and the stent thrombosis was not related to non target lesion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a previous medical history of aortic valve replacement.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7166999
• Report Number: 9612164-2018-00027
• Device Sequence Number: 13887371
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/03/2019

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 Date: 03/17/2019
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0008540218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 01/08/2018; 02/15/2018; 10/08/2018; 10/18/2018; 04/04/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/25/2018; 01/29/2018; 03/14/2018; 11/06/2018; 11/16/2018; 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 129