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

Model Number	RONYX35015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969)
Date of Event	12/17/2018
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 lad.It was reported the patient died.Safety assessed the event as not related to the index device or anti-platelet medication.
Additional Manufacturer Narrative
Additional information: an acute myocardial infarction occurred in an unknown vessel and this led to the death on the same day.The death classification is unknown.A dissection occurred in the lad during the procedure and this was not caused by a medtronic device; the dissection was treated with a resolute onyx des.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the investigator event as not related to the index device or anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the mi end point as no event.Cec adjudicated the death as cardiac death, possible stent thrombosis (lad).Safety assessment was updated to possibly related to index device.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: 8868576
• Report Number: 9612164-2019-03246
• Device Sequence Number: 18887459
• Product Code: NIQ
• UDI-Device Identifier: 00643169557079
• UDI-Public: 00643169557079
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/30/2020

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: 01/07/2019
• Device Model Number: RONYX35015UX
• Device Catalogue Number: RONYX35015UX
• Device Lot Number: 0008440526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 09/20/2019; 01/09/2020
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/16/2019; 10/01/2019; 01/30/2020
• 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
• Patient Age: 85 YR
• Patient Weight: 50