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

Model Number	RONYX35018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/13/2019
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 index procedure, three resolute onyx drug eluting stents were implanted in the rca, r-pda and lad.Three euphora pta balloons were also used in these vessels.Approximately 2 weeks post procedure, patient suffered gastroenteritis with chest pain.Safety commented that gi bleed occurred.Patient was on dapt 24 hours prior to event.Sponsor assessed event is not related to device but possibly related to anti platelet medication.
Additional Manufacturer Narrative
The index procedure was prompted by myocardial infarction.The patient has medical history of previous mi, pci, hyperlipidemia and hypertension.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: event term was updated to viral gastroenteritis.Patient recovered.Event was treated with medication.Investigator assessed that the event was not related to index device or antiplatelets medication.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: 9635920
• Report Number: 9612164-2020-00437
• Device Sequence Number: 16245789
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• 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,Followup
• Report Date (Section B): 02/28/2020

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: 09/05/2021
• Device Model Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0009903620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/18/2020; 02/24/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/19/2020; 02/28/2020
• 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: 57 YR
• Patient Weight: 117