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

Catalog Number	RONYX45012UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	12/13/2017
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 index procedure, five resolute onyx drug eluting stents were implanted; four in the lad and one in the 1st diagonal and two nc euphora balloons were used in the lad.On the same day, patient suffered elevated troponin and recovered the following day.Cec adjudicated the event as non-q wave myocardial infarction of the target vessel.Investigator assessed the event is unlikely related to device and not related to antiplatelet medication.
Additional Manufacturer Narrative
Cec adjudication; cec adjudicated stent thrombosis as not an event.Cec adjudicated non q wave mi (tv) as a non event.Patient has a medical history of hyperlipidemia, chronic renal insufficiency, multi-vessel coronary artery disease, and previous pci.During the index procedure, two resolute onyx drug-eluting stents were implanted in the 1st diagonal and three implanted in the lad.Orbital atherectomy of lad was also performed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudication still non-q-wave mi (target vessel), mdt extended historical 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: 8150438
• Report Number: 9612164-2018-03549
• Device Sequence Number: 13526972
• Product Code: NIQ
• UDI-Device Identifier: 00643169557239
• UDI-Public: 00643169557239
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup,Followup
• Report Date (Section B): 03/14/2019

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: 02/14/2019
• Device Catalogue Number: RONYX45012UX
• Device Lot Number: 0008495772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 11/15/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/21/2018; 03/14/2019
• 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: 80 YR
• Patient Weight: 115