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

Model Number	ONYXNG25038UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure one 2.5x38mm onyx frontier coronary drug eluting stent (des) dislodged during removal following a failed delivery.The lesion being treated was moderately tortuous, severely calcified with 90% stenosis and located in the mid diagonal branch.The device was inspected prior to use and negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.The dislodged stent was being removed with a snare; however, during removal it snagged a 3.0x30mm onyx frontier des which had been previously implanted at the ostium of the left circumflex artery (lcx).The 3.0x30mm onyx frontier des had some struts extending into the left main (lm) artery and had been implanted approximately eighteen days previously.Intravascular ultrasound (ivus) showed that the wire intended for the diagonal went through one of the cells of the 3.0x30mm onyx frontier des, and when the snared 2.5x38mm onyx frontier des was removed it pulled the 3.0x30mm onyx frontier des out with it.During the initial procedure the 3.0x30mm onyx frontier des had been inspected prior to use and was negatively prepped without issues.The lesion had been pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encoun tered when advancing this device and no excessive force was used during delivery. no further patient complications have been reported as a result of this event.
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
Additional information: resistance was noted advancing the 2.5x38mm stent.Once the stents were pulled out of the patient's arteries, the procedure was ended.There was no patient harm symptoms.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: intravascular ultrasound (ivus) showed that the non-medtronic wire intended for the diagonal went through one of the cells of the 3.0x30mm onyx frontier des, and when the snared 2.5x38mm onyx frontier des was removed it pulled the 3.0x30mm onyx frontier des out with it.It was later detailed that both stents were pulled out together with a snare.Image analysis: one image received depicts what appears to be a damaged stent caught on the distal end of a snare, within a reticule.It is unclear whether the image shows one or two stents, or whether the stent(s) are dislodged or expulsed.Based on the image alone, the presence of deformation can be conclusively confirmed.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: two dislodged and deformed stents were returned in the distal end of a snare device.The two stents are entangled in each other.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: 22297031
• Report Number: 9612164-2025-03060
• Device Sequence Number: 18257322
• Product Code: NIQ
• UDI-Device Identifier: 00763000511357
• UDI-Public: (01)00763000511357(17)271218(10)0012590771(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/19/2025

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: ONYXNG25038UX
• Device Catalogue Number: ONYXNG25038UX
• Device Lot Number: 0012590771
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 08/04/2025; 09/18/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/29/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 80 KG