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

Model Number	RONYX20008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	02/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, one resolute onyx rx (2.00x12) was attempted to be used and one resolute onyx rx (2.00x08) was implanted to treat a moderately tortuous, moderately calcified lesion located in the proximal circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.It was reported that the resolute onyx (2.00x12) stent failed to cross the lesion.The lesion was treated by pre-dilation using a non medtronic balloon and a resolute onyx (2.00x08) was implanted to complete the procedure.It was reported that the patient suffered a cardiac arrest and deceased following the procedure.
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: 10004210
• Report Number: 9612164-2020-01697
• Device Sequence Number: 16266524
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: 09/17/2021
• Device Model Number: RONYX20008UX
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0009926452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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
• Patient Age: 55 YR