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

Catalog Number	RONYX22538UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)
Date of Event	12/03/2018
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 drug eluting stent was implanted into the lad.Approx 7 days post index procedure, the patient suffered acute nstemi.The nstemi was caused by stent thrombosis.The patient was treated with balloon angioplasty of the lad.The patient recovered.The investigator assessed the event as unlikely related to the index device but causally related to anti-platelet medication.Safety assessed the event as possibly related to the index device and causally related to anti-platelet medication.
Additional Manufacturer Narrative
The investigator assessed the stent thrombosis as not related to the device but probably related to anti-platelet medication.Safety assessed the stent thrombosis as possibly related to the device and probably related to anti-platelet medication.The patient was not on dapt at the time of the event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated stent thrombosis of the target lesion stent, subacute stent thrombosis arc definite.Thrombotic occlusion after pci.Adjudicated target lesion revascularization is clinically driven.Also adjudicated mi is a non-q-wave mi (target vessel), udmi spontaneous.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event was treated with medication change.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
100% stenosis of the lad was reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 8188861
• Report Number: 9612164-2018-03759
• Device Sequence Number: 13928419
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/23/2019

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: 07/02/2020
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0009215785
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 04/01/2019; 04/22/2019; 05/02/2019; 05/02/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/09/2019; 04/05/2019; 05/09/2019; 05/23/2019; 05/23/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 94