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

Catalog Number	RONYX30038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/16/2019
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
During index procedure, four resolute onyx drug-eluting stents were implanted in the lad, r-pda and rca.Approximately 21 months post procedure, patient suffered acute blood loss anemia secondary to prepyloric ulcer.Event was treated with blood transfusion and me dication.Patient was on dapt within 24 hours prior to event.Sponsor assessed event as not related to device but possibly related anti platelet medication.
Additional Manufacturer Narrative
Additional information: during index procedure three resolute onyx drug-eluting stents were implanted in the lad, r-pda and rca.The fourth resolute onyx dr ug-eluting stent was implanted during a revascularization procedure 13 months post index procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient recovered.Investigator assessed that the event was unlikely related to device and 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: 9144298
• Report Number: 9612164-2019-04178
• Device Sequence Number: 2802785
• Product Code: NIQ
• UDI-Device Identifier: 00643169557048
• UDI-Public: 00643169557048
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 04/25/2019
• Device Catalogue Number: RONYX30038UX
• Device Lot Number: 0008599884
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 10/31/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/23/2019; 11/14/2019
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 112