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

Catalog Number	RONYX40012UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	02/04/2019
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 one resolute onyx des was implanted in the rca.Approximately 4 days post index procedure the patient suffered a transient ischemic attack (tia).The patient recovered.The investigator and sponsor assessed that the event is not related to the index device or anti platelets.The cec adjudicated the event as an embolic ischemic stroke.The cec adjudicated the event date as (b)(6) 2019.
Additional Manufacturer Narrative
Patient is a former smoker with a medical history of hypertension, stroke, previous cabg, previous pci and atrial fibrillation.Index procedure was promoted by stable angina and positive functional study.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient race updated to multiracial.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: 8495386
• Report Number: 9612164-2019-01209
• Device Sequence Number: 1062806
• Product Code: NIQ
• UDI-Device Identifier: 00643169557154
• UDI-Public: 00643169557154
• 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
• Report Date (Section B): 10/22/2019

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: 07/12/2020
• Device Catalogue Number: RONYX40012UX
• Device Lot Number: 0009235398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 10/11/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/08/2019; 10/22/2019
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 79