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

Catalog Number	RONYX22508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/03/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the index procedure two resolute onyx stents were implanted into the 2nd obtuse marginal.Approx 13 days post index procedure the patient died.The investigator assessed the event as not related to the index device or anti-platelet medication.Safety assessed the event as possibly related to the index device or anti-platelet medication.
Additional Manufacturer Narrative
The index procedure was prompted by mi.The ae term was updated to aortic stenosis.Cec assessed the event as death, cardiac.Cec commented that the patient had severe aortic stenosis.In hospice care.Unlikely to be stent thrombosis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient also has a medical history of chf.The patient was treated with medication prior to death.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: 8473980
• Report Number: 9612164-2019-01120
• Device Sequence Number: 1920581
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• 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): 05/23/2019

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: 07/11/2020
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0009231042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 04/23/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/09/2019; 05/23/2019
• 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: Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 77