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

Model Number	RONYX35022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101)
Date of Event	01/08/2019
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 two resolute onyx rx coronary des were implanted in the obtuse marginal.Approx 17 months later the patient suffered non-stemi (non target vessel).Angio revealed 70-80% stenosis of lad.Investigator assessed event is not related to device or anti platelet medication.The sponsor assessed the event as not related to the device and possibly related to the medication.Revascularization was carried out to treat the lad (non-tvr).The patient recovered.Cec adjudicated non-q-wave mi of target vessel, medtronic extended historical spontaneous in the lad.Cec adjudicated that late stent thrombosis arc definite was noted.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 9773580
• Report Number: 9612164-2020-00942
• Device Sequence Number: 2216018
• Product Code: NIQ
• UDI-Device Identifier: 00643169557093
• UDI-Public: 00643169557093
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• 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: 02/15/2019
• Device Model Number: RONYX35022UX
• Device Catalogue Number: RONYX35022UX
• Device Lot Number: 0008497043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82