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

Catalog Number	RONYX25034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/29/2017
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 inserted into the guide catheter but not implanted.On the same day, the patient suffered elevated cardiac enzymes.The patient recovered.The investigator assessed the event as not related to the index device or anti-platelet medication.The cec adjudicated the event as a non q wave mi (target vessel) mdt extended historical peri-pci.The mi occurred in the lad.The cec also adjudicated stent thrombosis as no event.
Additional Manufacturer Narrative
The patient has a medical history of ef (ejection fraction) of 15-20%.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was confirmed that the resolute onyx stent that was inserted into the guide catheter but not implanted, did not contribute to the mi.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed mi as non q wave mi (tv), scai definition peri-pci.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: 8077666
• Report Number: 9612164-2018-03236
• Device Sequence Number: 19413739
• Product Code: NIQ
• UDI-Device Identifier: 00643169556850
• UDI-Public: 00643169556850
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/12/2019

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: 05/28/2019
• Device Catalogue Number: RONYX25034UX
• Device Lot Number: 0008652842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 12/12/2018; 10/18/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/16/2018; 01/09/2019; 03/12/2019
• 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
• Patient Age: 59 YR
• Patient Weight: 70