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

Model Number	RONYX45018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Occlusion (1984); Thrombus (2101); Stenosis (2263)
Date of Event	12/07/2017
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 one resolute onyx des was implanted in the rca.On the same day the patient suffered right coronary artery intramural hematoma.A revascularization of the target vessel was carried out to treat in stent restenosis <(>&<)> acute thrombosis.Three resolute onyx stents were implanted in the rca.The patient recovered.The investigator has assessed that the event is unlikely to be related to the device and not related to antiplatelet/ anticoagulant medication.
Additional Manufacturer Narrative
It was reported that two resolute onyx devices were implanted in the rca during index procedure.The right coronary artery intramural hematoma event was then treated with two resolute onyx devices implanted in the target vessel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that intramural hematoma occlusion of the rca proximal and distal to the index stent was observed.Cec assessed mi as no event and the revascularisation as tlr pci clinically driven.The patient recovered.Age of patient also updated.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.
Additional Manufacturer Narrative
Correction: the date mfr rec of regulatory rep #:9612164-2018-00643 should be 2020-06-16.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the sponsor assessed the event as unlikely related to the device and not related to the anti-platelet medication.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: 7397339
• Report Number: 9612164-2018-00643
• Device Sequence Number: 69612
• Product Code: NIQ
• UDI-Device Identifier: 00643169557253
• UDI-Public: 00643169557253
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/01/2020

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: 02/11/2019
• Device Model Number: RONYX45018UX
• Device Catalogue Number: RONYX45018UX
• Device Lot Number: 0008493387
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 05/04/2018; 10/18/2018; 11/17/2018; 06/16/2020; 06/16/2020
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/16/2018; 11/16/2018; 12/12/2018; 07/01/2020; 07/01/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 83