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

Catalog Number	RONYX40008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/30/2017
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 cx.Cec adjuciated non-q-wave mi (target vessel), mdt extended historical peri-pci, same day as the index procedure, and adjudicated stent thrombosis as no event.
Additional Manufacturer Narrative
The patient also has a prior medical history of atherosclerosis, hypothyroidism, anemia, occlusion and stenosis of unspecified carotid artery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Patient is a former smoker.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: 8295885
• Report Number: 9612164-2019-00385
• Device Sequence Number: 2435022
• Product Code: NIQ
• UDI-Device Identifier: 00643169557147
• UDI-Public: 00643169557147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/28/2019

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: 03/29/2019
• Device Catalogue Number: RONYX40008UX
• Device Lot Number: 0008557015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/08/2019; 01/31/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/14/2019; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 85