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

Model Number	ONYXNG22515UX
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug-eluting stent to treat a lesion in the mid right coronary artery (rca).The device was inspected with no issues noted.Negative prep was performed with no issue noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was noted when advancing the device.It was reported that stent deformation occurred in vivo post-deployment.It was stated that the stent was deployed in the rca vessel, but the wire placement was lost.When trying to re-wire to post-dilate the stent with a balloon, the stent struts were pulled/unraveled due to the wire knuckle.It was noted that the proximal part of the stent was distorted, and it was planned to do another procedure on the patient 2 days later to open or crush the stent against the vessel wall.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: the lesion had 80-90% stenosis and was located in the mid-distal right coronary artery (rca).Excessive force was not used during delivery.The wire was a non-medtronic device.The second procedure was successfully completed on two days later.The original stent was crushed against the vessel with a new medtronic stent.No issues noted with the new stent on the follow up procedure.Device lot number provided.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.
Additional Manufacturer Narrative
Additional information: annex d codes.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: ONYX FRONTIER
• Common Device Name: 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: 19665151
• Report Number: 9612164-2024-03093
• Device Sequence Number: 6848034
• Product Code: NIQ
• UDI-Device Identifier: 00763000511203
• UDI-Public: 00763000511203
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 07/30/2024

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 Model Number: ONYXNG22515UX
• Device Catalogue Number: ONYXNG22515UX
• Device Lot Number: 0012063303
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/06/2024; 07/23/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/22/2024; 07/30/2024
• Date Device Manufactured: 12/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown