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

Catalog Number	RONYX40022UX
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	07/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Index procedure was prompted by positive functional stress test.A resolute onyx drug eluting stent was implanted in the lad during the index procedure.On the same day of index procedure, patient suffered mi and occlusion in the target vessel (no reflow in the coronary artery post stent deployment) and was treated with medication.Investigator assessed that the event is probably related to the study device.Patient recovered.
Additional Manufacturer Narrative
Cec assessed the mi as no event.The patient has a medical history of acute systolic heart failure and coronary heart disease.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: 6753287
• Report Number: 9612164-2017-00969
• Device Sequence Number: 16171541
• Product Code: NIQ
• UDI-Device Identifier: 00643169557185
• UDI-Public: 00643169557185
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 02/15/2019
• Device Catalogue Number: RONYX40022UX
• Device Lot Number: 0008497044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 11/16/2018
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 89