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

Model Number	RONYX30030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Obstruction/Occlusion (2422)
Date of Event	09/09/2020
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 a resolute onyx des was implanted in the lad.During a revascularization procedure two resolute onyx des were implanted in the rca.During a second revascularization procedure one resolute onyx des was implanted in the rca and one resolute onyx des was implanted in the rpl.During a third revascularization procedure two resolute onyx des were implanted in the rca.During a fourth revascularization procedure one resolute integrity bms as implanted in the rca.During a fifth revascularization procedure to treat severely calcified rca and intent restenosis of the mid rca plaque prolapse was noted and the patient was treated with two medtronic stents in the rca.The plaque prolapse was not present prior to the stent in the mid rca, prolapse occurred after the post dilation of mid rca.Plaque prolapse caused occlusion in the ostial rca therefore ostial rca was stented.The patient was discharged home.Investigator assessed the event as not related to index device or anti-platelet medication.The sponsor assessed the event as not related to the anti-platelet medication and unlikely related to the index device.The plaque prolapse was not present prior to the stent in the mid rca, prolapse occurred after the post dilation of mid rca.Plaque prolapse caused occlusion in the ostial rca therefore ostial rca was stented.
Additional Manufacturer Narrative
Correction: during a revascularization procedure one integrity bms was implanted in the rca.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 10710437
• Report Number: 9612164-2020-04023
• Device Sequence Number: 16937420
• Product Code: NIQ
• UDI-Device Identifier: 00643169557024
• UDI-Public: 00643169557024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 02/26/2022
• Device Model Number: RONYX30030UX
• Device Catalogue Number: RONYX30030UX
• Device Lot Number: 0010155436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/09/2023
• Date Device Manufactured: 02/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White