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

Catalog Number	RONYX27508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During index procedure one resolute onyx des was implanted in the mid lad and one resolute onyx des was implanted in the 1st om.During stenting of the lad there was acute closure of 2.5 mm side branch of the vessel.Revascularization was attempted but unsuccessful and the physician elected to treat medically.
Additional Manufacturer Narrative
The investigator reported that the event has a probable relationship to the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: the investigator reported that the event has a probable relationship to the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The investigator assessed the event as not related to anti-platelet medication.Patients race and ethnicity received.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: 6763550
• Report Number: 9612164-2017-00999
• Device Sequence Number: 1490296
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/22/2019

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: 01/20/2019
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008459056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 10/19/2017; 10/19/2017; 01/18/2019
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 11/07/2017; 11/07/2017; 01/22/2019
• 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: Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 74