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

Model Number ONYXNG50022UX

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

The patient presented to hospital with declining left ventricular function and shortness of breath (angina), for diagnostic cardiac catheterization.Indication for percutaneous coronary intervention (pci) was angina and congestive heart failure.An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a moderately tortuous, moderately calcified lesion with 80% stenosis in the proximal right coronary artery (rca).The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated with a 4.0x12mm balloon to 14atm.The device did not pass through a previously deployed stent.Resistance was noted while advancing the device.Excessive force was not used.It was reported that stent deformation occurred in vivo during positioning/advancement.The rca was engaged with a 6f guide catheter.A 300cm 0.014 non-medtronic (mdt) guidewire was advanced beyond the culprit lesion, distally in the vessel, without complication.Intravascular ultrasound (ivus) was performed with a non-mdt device.Difficulty was noted during advancement of the onyx frontier device through a telescope guide extension catheter before it reached the vessel.The stent system was pulled back, and the stent was deformed and partially dislodged off the balloon.A 5.0x18mm non-mdt stent was then used, and there were no issues when using this device and the same telescope device.The lesion was stented with the5.0x18mm non-mdt des to 12atm.The patient is alive with no 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.

Manufacturer Narrative

Product analysis: the device was received for analysis.A kink was evident immediately distal to the luer.The stent had displaced proximally on the balloon and was not positioned on the balloon between the markerbands as per specifications.The proximal stent wraps were positioned over the proximal markerband.The stent was not positioned against the distal pillow as per specification.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the proximal and distal stent wrap with struts raised and bunched.The inner lumen patency was verified with a 0.015-inch mandrel.No other damage evident to the remainder of the device.Image analysis: fluoroscopic images show the presence of a tight lesion in the proximal rca.The lesion was pre-dilated with partial but not full resolution of the stenosis.No images were provided showing the attempted but unsuccessful delivery of the stent through the guide catheter and guide extension catheter.Only images of the vasculature were provided and it was reported that the stent did not enter the vasculature.A non-medtronic stent was delivered and deployed across the 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.

Manufacturer Narrative

Additional information: a pull was felt while advancing the stent through the guide and the telescope guide extension catheter.It was stated that the dislodgement occurred in the guide and that the stent never made it to the coronary arteries.The system was pulled back before advancing any further without any additional issues.The dislodged stent was removed by pulling the stent delivery system back out through the guide.Resistance was not noted during withdrawal of the device and excessive force was not used.There was no deformation noted to the telescope device and the replacement stent passed with no issues.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: annex d code added.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18501555
• MDR Text Key: 332733861
• Report Number: 9612164-2024-00217
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511814
• UDI-Public: 00763000511814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG50022UX
• Device Catalogue Number: ONYXNG50022UX
• Device Lot Number: 0011049800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/17/2024; 01/30/2024
• Supplement Dates FDA Received: 01/24/2024; 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 90 KG