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

Catalog Number	RONYX27512UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/10/2017
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 stent was implanted into the lad and three resolute onyx stent were implanted into the lcx.One day post procedure the patients cardiac enzymes were elevated.Cec assessed the event as non q wave mi (target vessel), mdt extended historical peri pci.Cec also assessed stent thrombosis as no event.
Additional Manufacturer Narrative
It was reported that event occurred (b)(6) 2017 and not (b)(6) 2017 as previously reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec re adjudicated mi of the lad and cx as no event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the event as myocardial infarction.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: 8372958
• Report Number: 9612164-2019-00678
• Device Sequence Number: 1332364
• Product Code: NIQ
• UDI-Device Identifier: 00643169556881
• UDI-Public: 00643169556881
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/03/2019

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: 03/23/2019
• Device Catalogue Number: RONYX27512UX
• Device Lot Number: 0008547669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/14/2019; 03/22/2019; 06/10/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/15/2019; 04/19/2019; 07/03/2019
• 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
• Patient Age: 89 YR
• Patient Weight: 76