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

Catalog Number	RONYX30008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism (1829)
Date of Event	06/07/2019
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 three resolute onyx des were used to treat the lad and cx.During a staged procedure three days later, one resolute onyx des was used to treat the rca.Approximately 2 months post procedures the patient suffered a stroke and was treated with medication.The sponsor assessed the event as not related to the index device or the anti-platelet medication and the patient is recovering.
Additional Manufacturer Narrative
The site assessed the event as not related to the device or to the antiplatelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated event as ischemic stroke.Correction: stroke is noted to be cardio embolic.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: patient race added.Hospitalization ticked.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: 8770548
• Report Number: 9612164-2019-02753
• Device Sequence Number: 11135193
• Product Code: NIQ
• UDI-Device Identifier: 00643169556966
• UDI-Public: 00643169556966
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2019

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: 01/05/2021
• Device Catalogue Number: RONYX30008UX
• Device Lot Number: 0009521509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 08/23/2019; 06/18/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/25/2019; 09/04/2019; 11/27/2019
• 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; Other
• Patient Age: 86 YR
• Patient Weight: 71