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

Catalog Number	RONYX50030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	11/13/2018
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 rca.It was reported that during the procedure, a dissection occured in the rca, this was treated with the implantation of a resolute onyx des.It is unknown if a medtronic device caused the dissection.
Additional Manufacturer Narrative
The sponsor assessed that this event had a casual relationship with the device, but not related to the anti platelets.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The investigator reported that the event was not related to the device or antiplatelet medication.It was reported that a medtronic device did not cause the dissection.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: 8168632
• Report Number: 9612164-2018-03640
• Device Sequence Number: 1459452
• Product Code: NIQ
• UDI-Device Identifier: 00643169557345
• UDI-Public: 00643169557345
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2019

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: 07/11/2019
• Device Catalogue Number: RONYX50030UX
• Device Lot Number: 0008709016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 04/03/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/08/2019; 05/01/2019
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 149