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

Model Number	ONYXNG30015UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Insufficient Information (4580)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure involving one onyx frontier coronary drug-eluting stent, the stent dislodged during advancement into a lesion inside a previously implanted stent.The lesion was located proximally in the right coronary artery (rca) with moderate tortuosity, severe calcification and 70% stenosis.The stent dislodgement occurred during delivery to the lesion, and it was believed to have been caught on the previous stent.The dislodged stent was successfully removed using a snare while it was still on the guide wire.The device was inspected prior to use with no issues noted.Negative prep was not performed.The lesion was pre-dilated.Resistance was encountered during device advancement however 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: the lesion is discreet and was previously treated with a stent and angioplasty.The previously implanted stent had severe in stent r estenosis.The onyx frontier stent was initially inserted but was removed intact and undeployed as it was unable to cross the lesion.Further lesion ballooning was performed with a 3.0x8mm nc euphora balloon.The stent was reinserted, and dislodgement occurred dur ing delivery to the lesion, and it was believed to have been caught on the previous stent.Resistance was not noted during withdrawal of the device, and excessive force was not used.Another 3.0x12mm onyx frontier des was successfully placed and deployed the 3.0x8mm nc euphora balloon was used to post dilate the stent at 16 atm for 15 seconds.There was no damage noted to the previously implanted stent.There was post intervention timi flow iii with 0% residual stenosis.The patient had a hematoma post procedure with associated groin pain.Pressure was held to treat the hematoma.Two 6f launcher guide catheters were also used during the procedure.Patient initials and relevant history updated.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: the nc euphora balloon and the two 6f launcher guide catheters were used during the procedure with no issues.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 for analysis.The device was returned with no stent on the balloon.Stent crimp impressions were visible on the balloon.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: 21916374
• Report Number: 9612164-2025-02071
• Device Sequence Number: 15615989
• Product Code: NIQ
• UDI-Device Identifier: 00763000511470
• UDI-Public: 00763000511470
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/19/2025

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: ONYXNG30015UX
• Device Catalogue Number: ONYXNG30015UX
• Device Lot Number: 0012641343
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/20/2025; 06/18/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/20/2025; 05/28/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 111 KG