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

Model Number	RONYX20030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/16/2019
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
The index procedure was prompted by mi.During the index procedure, one resolute onyx des was implanted in the lad.The patient had a nosebleed and was treated with nasal cautery and recovered.The investigator assessed the event as not related to the index device or anti platelets.The sponsor assessed the event as not related to the device and possibly related to the anti platelets.The cec adjudicated a stroke occurred.
Additional Manufacturer Narrative
Additional information: the investigator assessed the event as possibly related to the anti-platelet medication correction: patient ethnicity outcome attributed to adverse event.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: 9201177
• Report Number: 9612164-2019-04393
• Device Sequence Number: 3031216
• Product Code: NIQ
• UDI-Device Identifier: 00643169556683
• UDI-Public: 00643169556683
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 05/24/2020
• Device Model Number: RONYX20030UX
• Device Catalogue Number: RONYX20030UX
• Device Lot Number: 0009157245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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: 75 YR
• Patient Weight: 98