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

Catalog Number	RONYX35026UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombus (2101); Stenosis (2263); Injury (2348)
Date of Event	07/08/2019
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 the index procedure one resolute onyx stent was implanted into the rca.Approx 7 months post index procedure the patient suffered cardiac chest pain.The patient was treated with stenting to treat stent thrombosis in the rca.The patient was also treated with a medication change.The patient was not on dapt at the time of the event.It was reported that the stent involved was resolute onyx lot: 0008847456.The patient is recovering.
Additional Manufacturer Narrative
Additional information: the event term was updated to coronary artery in stent restenosis.The patient recovered.Cec adjudicated the stent thrombosis as a non-event.Correction: the site assessed the event as probably related to the anti-platelet medication and possibly related to the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the revascularisation as target lesion clinically driven to treat in stent re-stenosis.The sponsor assessed the event as possibly related dot the index device.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: 8836692
• Report Number: 9612164-2019-03093
• Device Sequence Number: 2534508
• Product Code: NIQ
• UDI-Device Identifier: 00643169557109
• UDI-Public: 00643169557109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2019

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: 10/25/2019
• Device Catalogue Number: RONYX35026UX
• Device Lot Number: 0008847456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 11/08/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 07/30/2019; 11/27/2019
• 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; Other; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 70