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

Catalog Number	RONYX27530UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/29/2019
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 stent was implanted.It was reported the patient died.
Additional Manufacturer Narrative
The patient has a medical history of hypertension and diabetes.The index procedure was prompted by unstable angina and mi.During the index procedure the resolute onyx stent was implanted in the cx.Death was due to cardiac arrest, pneumonia and respiratory failure.The sponsor and investigator assessed these events 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
The patient was treated with medical/surgical intervention.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated death as cardiac.Patient weight corrected.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the sponsor assessed the event as possibly related to the 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: 8854150
• Report Number: 9612164-2019-03193
• Device Sequence Number: 11400120
• Product Code: NIQ
• UDI-Device Identifier: 00643169556935
• UDI-Public: 00643169556935
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 10/29/2019

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: 03/14/2019
• Device Catalogue Number: RONYX27530UX
• Device Lot Number: 0008534809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 08/16/2019; 10/09/2019; 10/21/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/14/2019; 09/06/2019; 10/18/2019; 10/29/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 68