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

Model Number	ONYXNG25034UX
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion with 80% stenosis in the mid obtuse marginal (om).The device was inspected prior to use with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that to protect the side branch from plaque shift the lesion was wired with a non-medtronic (mdt) guidewire.The onyx frontier device was deployed across this side branch, trapping the non-mdt guidewire behind the onyx frontier.The proximal end of the onyx frontier device was about 20 mm proximal to the wired side branch.It was not possible to remove the trapped wire.An attempt was made to advance several low-profile balloons on the trapped wire hoping they could slip behind the stent and free the wire.After several unsuccessful attempts and as a result of pulling on the wire, the wire fractured, leaving the wire in the patient vasculature.The wire was successfully removed during surgery.No damage was caused to the onyx frontier stent as a result of the wire was being pulled or when the wire detached.The onyx frontier device remains implanted.The patient is reported to be alive with no further 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: it was reported that to protect the side branch from plaque shift the lesion was wired with a.014 non-medtronic (mdt) guidewire.Annex d codes 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: 15994457
• Report Number: 9612164-2022-04772
• Device Sequence Number: 5710063
• Product Code: NIQ
• UDI-Device Identifier: 00763000511340
• UDI-Public: 00763000511340
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2024
• Device Model Number: ONYXNG25034UX
• Device Catalogue Number: ONYXNG25034UX
• Device Lot Number: 0011221549
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/26/2023
• Date Device Manufactured: 05/20/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG