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

Catalog Number ONYXNG35022X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Stenosis (2263); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

During the index procedure one onyx frontier coronary drug eluting stent was implanted in the proximal circumflex (cx).During the procedure one euphora rx ptca balloon catheter was also used for pre-dilation.Approximately 6 days post procedure the patient suffered with chest pain and raised troponin.Stent thrombosis and in-stent restenosis were confirmed by angio and occurred in the onyx frontier drug eluting stent.It was also observed that the stent was under inflated.The proximal cx onyx frontier stent was expanded.New target lesions were also reported in the distal cx and second obtuse marginal artery.The event was treated with a percutaneous coronary intervention during which three onyx frontier des, three euphora rx balloons and three nc euphora balloons were used to treat the proximal/distal cx and the 2nd obtuse marginal arteries.It was stated that this was a clinically driven target lesion revascularization.The patient recovered.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.The investigator assessed the event as causally related to the device and procedure.The sponsor assessed the event as possibly related to the device and procedure.

Manufacturer Narrative

Additional information: during the index procedure, there were no issues noted to the onyx frontier device before use.Resistance was not noted while advancing the device to the lesion.Difficulties were not noted during inflation of the device.There were no issues noted during post-dilation of the device.There was no issue or complaint with the euphora device used in the index procedure.There were no issues or complaints with the three onyx frontier devices or with any of the three euphora or three nc euphora devices used during the revascularization procedure.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

Image analysis: images provided were from the index procedure and of the follow up procedure.The index procedure images confirming the pre-dilation of the target lesion and the deployment of a stent in the proximal lcx.There did appear to have been difficulties during delivery of the procedural wire, most likely due to tortuosity in the vessel.But this was achieved successfully.After pre-dilation the stent was successfully deployed in the proximal vessel.No evidence of stent malapposition, vessel fracture or any other issue that could have contributed to the subsequent stent thrombosis, myocardial infarction (mi) and reported in-stent restenosis (isr).Although the stent was not post dilated and this may have contributed to the reported possible stent malapposition reported from the account.The images from the follow up procedure confirm lcx occlusion due to thrombus in the lcx.The reported restenosis could not be confirmed, and it did not appear that the onyx frontier stent was malapposed.The lcx was ballooned followed by stenting in the lcx and in the om2.The stents, including the stent deployed in the index procedure, were ballooned as reported in the event description.Final angiographic results show that the occlusion and thrombus and the reported malapposition were resolved.In order to support root cause determination a medical safety review was performed by a medtronic medical safety specialist.Medical safety review determined that this event cannot exclude relations to the stent, however the more relevant factors are anatomy (tortuosity) and procedural (technique and initial/index case outcome).For the index procedure it was determined that sizing (for vessel diameter) was the issue.The chosen length of the stent might be in question.However, ivus was performed prior to stent deployment (and after).With that said, there was no calcification to note but there was tortuosity, and therefore, malapposition is possible, especially as post dilation is not seen.There are no procedural complications, however there is noted stenosis remaining at om2 and distal to the implanted stent.Specialist review of the follow-up procedure determined that the runoff distal to the implanted stent is blocked with an appearance consistent with st.Om2 still showing stenosis at its take off from lcx (ostial).Following guidewire access, pre-dilation and ivus om2 appears occluded.Multiple pre-dilitations continue, followed by stenting and post-dilation in the distal lcx and om2.Persistent stenosis/haziness could be observed in the ostial om2, managed by additional post dilations with a shorter balloon.Final angiographic outcomes without complications.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: it was stated that this was a clinically driven revascularization and the revascularization in the distal cx and 2nd obtuse marginal was classified as an other lesion in the target vessel and the proximal cx was classified as a target lesion.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: ONYX FRONTIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17048883
• MDR Text Key: 316383190
• Report Number: 9612164-2023-02377
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ONYXNG35022X
• Device Lot Number: 0011358513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Date Device Manufactured: 08/17/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG