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

Model Number	RONYX40018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Thrombus (2101)
Date of Event	08/06/2019
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
During index procedure, two resolute onyx drug-eluting stents were implanted; one in the graft 2nd diagonal.Approximately 24 months post procedure, patient death was reported.Cause of death is unknown.The investigator and sponsor assessed the event is not related to device or anti-platelet medication.
Additional Manufacturer Narrative
Additional information: during index procedure,one resolute onyx drug-eluting stent was implanted in the 2nd diagonal graft, during a later procedure a second resolute onyx drug-eluting stent was implanted in the 2nd diagonal graft.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected information: during the index procedure, a resolute onyx drug-eluting stent was implanted in the 2nd diagonal graft.During another procedure a second resolute onyx des was implanted in the target vessel 2nd diagonal graft.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated death as a non-cardiac death and commented "patient had a very large aaa (abdominal aortic aneurysm), chf (congestive heart failure) and possibly st (stent thrombosis)".If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec identified stent thrombosis, event date (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated death as cardiac.Safety comment was also updated to cardiac death.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: 9127576
• Report Number: 9612164-2019-04122
• Device Sequence Number: 3070439
• Product Code: NIQ
• UDI-Device Identifier: 00643169557178
• UDI-Public: 00643169557178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/24/2020

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: 02/10/2019
• Device Model Number: RONYX40018UX
• Device Catalogue Number: RONYX40018UX
• Device Lot Number: 0008492683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/30/2019; 03/05/2020; 03/05/2020; 03/27/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 09/27/2019; 10/14/2019; 03/13/2020; 03/19/2020; 04/24/2020
• 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: Death
• Patient Age: 88 YR
• Patient Weight: 78