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

Catalog Number	RONYX30026W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a stage procedure, one resolute onyx was used to treat a prox cx.During the procedure a plaque / carina shift occurred and a second resolute onyx was used to treat it.
Additional Manufacturer Narrative
The patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event has been assessed as possibly related to the device and not related to antiplatelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The lcma was also treated during the staged procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The stent implanted in the lcma was to treat the plaque shift that occurred during staged procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7057022
• Report Number: 9612164-2017-01661
• Device Sequence Number: 16182135
• Product Code: NIQ
• UDI-Device Identifier: 00643169602533
• UDI-Public: 00643169602533
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2018

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: 02/28/2019
• Device Catalogue Number: RONYX30026W
• Device Lot Number: 0008515343
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 11/30/2017; 01/11/2018; 08/28/2018; 09/27/2018
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 12/14/2017; 01/18/2018; 09/27/2018; 10/15/2018
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 73