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

Catalog Number	RONYX27512UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/01/2018
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 the distal rca was treated with one resolute onyx drug eluting stent.Approximately 8 months post index procedure the patient suffered a gi bleed.The patient was on dual antiplatelet therapy at the time of the event.The patient was treated with upper endoscopy, colonoscopy, blood transfusion and medication.The investigator assessed that the event was not related to the index device but probably related to anti-platelet medication.The patient recovered.
Additional Manufacturer Narrative
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: 7376735
• Report Number: 9612164-2018-00585
• Device Sequence Number: 19106876
• Product Code: NIQ
• UDI-Device Identifier: 00643169556881
• UDI-Public: 00643169556881
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/28/2018

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: 03/11/2019
• Device Catalogue Number: RONYX27512UX
• Device Lot Number: 0008532724
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 53