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

Model Number	ONYXNG30018UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
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
It was reported that during a procedure involving one onyx frontier coronary drug eluting stent a rupture of the stent delivery balloon occurred.It was noted that blood was flowing into the inflation device when the device was being negatively prepped at the lesion.Negative atm was applied when the rupture occurred, and it was not possible to pull negative to prep the stent inside the patient due to the rupture.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: a non-medtronic inflation device was used.The stent was prepped in the body which was when it was noted that there was blood in the shaft.The lesion being treated had no calcification or no degree of tortuosity and was described as subtotal occlusion with a thrombosed segment with timi 1 flow in the mid left anterior descending artery (lad).The device was inspected before use with no issues noted.The lesion was not pre-dilated.Resistance was not noted while advancing the device.The device was not moved or repositioned in the lesion during negative prep.The procedure was completed using the same inflation device.The patient was discharged home.A.Patient information: patient age, sex, gender, weight provided.B7.Relevant history 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
Product analysis: the device was returned with biologics in the luer.The stent was positioned on the balloon as per specification.An indeflator with pressure gauge was used to inflate the device but the balloon would not inflate, and biologics/water leaked out through the rx joint and the tip, indicating a leak in the inner.A visual inspection could not find the leak site on the inner.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: 22002805
• Report Number: 9612164-2025-02341
• Device Sequence Number: 21179746
• Product Code: NIQ
• UDI-Device Identifier: 00763000511487
• UDI-Public: (01)00763000511487(17)271130(10)0012565547(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/04/2025

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: ONYXNG30018UX
• Device Catalogue Number: ONYXNG30018UX
• Device Lot Number: 0012565547
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/03/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2024
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 113 KG