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

Model Number	RONYX22538UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Stenosis (2263); Injury (2348)
Date of Event	04/17/2019
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 one resolute onyx drug eluting stent (ronyx22538ux) was implanted in the lad.One resolute onyx drug eluting stent (ronyx22522ux) was implanted in the cx during a planned staged procedure.On the same day as the staged procedure the patient suffered in-stent coronary artery restenosis treated with revascularization of the lad (cass 13).The patient recovered.The investigator assessed the event as not related to the anti-platelet medication or the device.The sponsor assessed the event as not related to the anti-platelet medication and possibly related to the device.Cec adjudicated the revascularization as no event and commented "no change.Staged procedure with plaque shift from ostial lcx and distal left main to ostial lad prompting rescue of lad." safety commented isr.

• 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: 9835794
• Report Number: 9612164-2020-01195
• Device Sequence Number: 11553306
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 09/09/2020
• Device Model Number: RONYX22538UX
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0009318351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/16/2020
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73