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	Blood Loss (2597)
Date of Event	12/01/2019
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 lad.Approximately 9 months post index procedure, patient suffered from acute on chronic blood loss anemia.It was reported that the cause of bleeding was external hemorrhoids.Patient was on dapt 24 hours prior to event.Event was treated with blood transfusion.Investigator and sponsor assessed that the event was not related to index device, but possibly related to antiplatelets medication.Patient recovered.
Additional Manufacturer Narrative
Additional information: event description updated to "lower gi bleed." patient was not on dapt 24 hours prior to event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient was also treated with a change in 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: 9502802
• Report Number: 9612164-2019-05266
• Device Sequence Number: 1215568
• 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,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: 12/02/2019
• Supplement Date Received by Manufacturer: 12/05/2019; 02/27/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/21/2020; 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; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98