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

Model Number	ONYXNG22518UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 severely calcified lesion located in the mid diagonal branch.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with 2.0x12mm and 2.5x12mm non-medtronic balloons.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that stent dislodgement occurred during delivery to/at the lesion.The dislodged stent was removed.It was possible to pull the stent out as it was still on the wire.It was detailed that an old stent was already implanted in 1st diagonal and an attempt was being made to get the onyx frontier to the 2nd diagonal.The lesion was instead treated with just ballooning of the 1st diagonal area to make sure the previously implanted stent was still open.The patient is alive with no 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.
Additional Manufacturer Narrative
Product analysis summary: the stent returned on a non-medtronic wire.During analysis the stent was found to be deformed and dislodged.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 code.Correction product analysis: the delivery system did not return.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: 20451414
• Report Number: 9612164-2024-04706
• Device Sequence Number: 17919763
• Product Code: NIQ
• UDI-Device Identifier: 00763000511210
• UDI-Public: 00763000511210
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: ONYXNG22518UX
• Device Catalogue Number: ONYXNG22518UX
• Device Lot Number: 0012151867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 11/22/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/11/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2024
• 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: Unknown