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

Catalog Number	RONYX22534UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/29/2019
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 unstable angina.During the index procedure, two resolute onyx stents were implanted into the lad.Approx 25 days post index procedure, the patient suffered gi bleed.The patient was on dapt at the time of the event.The patient was treated with blood transfusion.The investigator assessed the event as not related to the device but possibly related to anti-platelet medication.The patient recovered.
Additional Manufacturer Narrative
Additional information: the patient was also treated with a change in medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: event was also treated with medication.Correction: patient has a medical history on anemia.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: 8347524
• Report Number: 9612164-2019-00541
• Device Sequence Number: 1923321
• Product Code: NIQ
• UDI-Device Identifier: 00643169556768
• UDI-Public: 00643169556768
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: 160043
• 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): 01/14/2020

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: 04/19/2020
• Device Catalogue Number: RONYX22534UX
• Device Lot Number: 0009092421
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 12/18/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 09/18/2019; 01/14/2020
• 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: 80 YR
• Patient Weight: 88