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

Model Number	RONYX30022W
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	08/12/2019
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
During the index procedure one resolute onyx des was used to treat the lad.Approximately 5.5 months post procedure patient suffered fatigue and dizziness.The patient died one day later.The investigator and sponsor assessed the event as not related to the index device and unlikely to the anti-platelet medication.
Additional Manufacturer Narrative
Additional information: ae term change to possible mi.Date of death changed to (b)(6) 2019.Death classified as non sudden cardiac death.It was reported that the patient may have suffered an mi prior to presenting to the er (unknown vessel).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the site assessed the event as unlikely to be related to the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the patient suffered a sudden cardiac death.The site assessed the event as not related to the anti-platelet medication.The sponsor assessed the event as possibly related to the device and not related to the anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the death as a cardiac death.Cec adjudicated the mi as a non-q-wave mi (vessel unknown), 3rd udmi spontaneous, cass site 990 - indeterminate; nstemi by source documentation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated an mi occurred (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8944078
• Report Number: 9612164-2019-03638
• Device Sequence Number: 16682054
• Product Code: NIQ
• UDI-Device Identifier: 00643169602526
• UDI-Public: 00643169602526
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/02/2020

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: 04/08/2020
• Device Model Number: RONYX30022W
• Device Catalogue Number: RONYX30022W
• Device Lot Number: 0009073234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 10/22/2019; 11/02/2019; 01/11/2020; 02/11/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/20/2019; 10/29/2019; 11/20/2019; 02/03/2020; 03/02/2020
• 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; Life Threatening; Disability
• Patient Age: 71 YR
• Patient Weight: 73