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

Catalog Number RONYX40030X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure, one resolute onyx stent was implanted into the rca.One day post index procedure the patient suffered coronary interventional mi.The mi occurred in the target vessel - rca.The patient was treated with medication and ballooning of the rca.The event is unresolved.The investigator and safety assessed the event as causally related to the index device and possibly related to anti-platelet medication.

Manufacturer Narrative

Additional information: sponsor assessed event is possibly related to antiplatelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec assessed the event as a q wave mi (target vessel), mdt extended historical peri-pci.Cec also assessed stent thrombosis as no event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec commented that the revascularisation occurred in the r-pda.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information patient recovered.Investigator assessed the event as unlikely related to anti-platelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the event was treated with ballooning of the r-pda.Correction (b)(6) 2019: the cec assessed the event as a non-q- wave mi (target vessel), mdt extended historical peri-pci.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient underwent revascularisation of both the r-pda and 1st rpl (target vessels) with stenting to treat the event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient recovered with sequelae.The cec also adjudicated the mi as a non q wave mi (target vessel), mdt extended historical spontaneous in the r-pda.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.

Manufacturer Narrative

Additional information: fdc/annex d code.Correction: during the revascularization a 2.5x18mm endeavor stent was used to cover the pl lesion and a 3.0x18mm endeavor stent was used to cover the pd lesion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: 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: 8269908
• MDR Text Key: 133828380
• Report Number: 9612164-2019-00273
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Catalogue Number: RONYX40030X
• Device Lot Number: 0009012820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Date Device Manufactured: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 87 KG