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

Model Number	ONYXNG20018UX
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug-eluting stent to treat a moderately tortuous, mildly calcified lesion in the distal left anterior descending (lad) artery. the device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The non-medtronic guidewire was examined and flushed before use.There were no issues/kinks noted.There were no difficulties noted when loading the device onto the guidewire.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during the delivery.It was reported that stent deformation occurred in vivo post-stent deployment.It was detailed that following inflation of the stent at nominal pressure, the stent was deployed.An attempt was made to remove the non-medtronic guidewire which was caught on the distal stent struts.The guide wire was only used with the stent prior to the issue occurring.Multiple attempts were made to remove the guide wire.The stent was deformed in the attempt to remove the guidewire.The 3mm tip of the guidewire broke off.The detached portion of the guidewire was not removed as it was stuck to the stent struts.The patient is alive with no injury.
Additional 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.
Additional Manufacturer Narrative
Additional information: there was no injury to the patient as a result of the event.Annex d code.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.
Additional Manufacturer Narrative
Additional information: event date updated.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
• Common Device Name: 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: 17640117
• Report Number: 9612164-2023-03884
• Device Sequence Number: 12160235
• Product Code: NIQ
• UDI-Device Identifier: 00763000511142
• UDI-Public: 00763000511142
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2025
• Device Model Number: ONYXNG20018UX
• Device Catalogue Number: ONYXNG20018UX
• Device Lot Number: 0011560472
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 10/06/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/20/2023; 10/11/2023
• Date Device Manufactured: 12/21/2022
• 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
• Patient Sex: Male