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

Catalog Number	RONYX45022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984)
Date of Event	08/24/2017
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 rx was implanted in the rca.On the same day, plaque prolapse during stent procedure was reported in the target vessel.The patient was treated with medication.The investigator assessed the event as casually related to the device and not related to the antiplatelet medication.The patient recovered.
Additional Manufacturer Narrative
Cec adjudicated the stent thrombosis as no event.The patient has a medical history of hypertension and previous mi.It was noted that following stent deployment, subject had transient no reflow, and st elevations were present in monitor.After treatment with medication, restoration of normal flow in vessel was noted and resolution of st elevations.Non q wave mi(tv) was adjudicated as a non-event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: cec adjudication: non-q wave mi (tv) mdt extended historical peri-pci patient medical history includes abdominal aortic aneurysm, congestive heart failure if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: investigator assessed the event as probable related to 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: 8105355
• Report Number: 9612164-2018-03365
• Device Sequence Number: 2118164
• Product Code: NIQ
• UDI-Device Identifier: 00643169557260
• UDI-Public: 00643169557260
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 03/25/2019

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: 02/07/2019
• Device Catalogue Number: RONYX45022UX
• Device Lot Number: 0008487240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 11/30/2018; 02/26/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/21/2018; 03/14/2019; 03/25/2019
• 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
• Patient Age: 69 YR
• Patient Weight: 92