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

Model Number	RONYX45015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/25/2019
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, one resolute onyx des was implanted in the lcma.Approximately 21 months post index procedure, patient was hospitalized post dialysis and died 2 days later.
Additional Manufacturer Narrative
Additional information: death event was classified as sudden cardiac death.Investigator assessed that the event was not related to index device or antiplatelets medication.It was indicated that the cause of death was lead by cardiopulmonary arrest, hypotension, mesenteric ischemia and bowel necrosis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: update 06 apr 2020: event onset date updated.Safety commented "death".If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event term has been updated to cardiopulmonary arrest with an outcome of 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: 9564270
• Report Number: 9612164-2020-00155
• Device Sequence Number: 3043151
• Product Code: NIQ
• UDI-Device Identifier: 00643169557246
• UDI-Public: 00643169557246
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/11/2020

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: 07/21/2019
• Device Model Number: RONYX45015UX
• Device Catalogue Number: RONYX45015UX
• Device Lot Number: 0008711941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/09/2020; 04/06/2020; 06/09/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/29/2020; 04/10/2020; 06/11/2020
• 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: Death; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Weight: 87