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

Model Number	ONYXNG27522UX
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the patient condition was normal at the start of the procedure.A standard concentration of contrast / saline was used.There were no difficulties noted when removing the protective sheath / packaging stylette from the device.Normal pre-treatments were done prior to balloon use.No adjunctive techniques were used to aid in delivery.The device was not moved or repositioned in the lesion.There were no difficulties noted during inflation of the device.The deflation difficulties were noted after the first inflation.The balloon was able to be deflated and the device was removed normally on the wire without issues.No intervention was required to remove the device.There was no kink noted on the device prior to the deflation difficulties.The procedure was completed using another onyx fronter device.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
During a procedure an attempt was made to use one onyx frontier coronary drug eluting stent when deflation difficulties were experienced.The device would not deflate at the lesion site.The catheter and stent were removed and a different device was used.The device was inspected prior to use with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The lesion being treated was a moderately tortuous, mildly calcified lesion with 70% stenosis located in the proximal left anterior descending (lad) artery.The device did not pass through a previously-deployed stent.There was no resistance encountered when advancing the device, and excessive force was not used during delivery.No patient complications were 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.

• Brand Name: ONYX FRONTIER
• Common Device Name: CORONARY DRUG-ELUTING STENT
• 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: 25081119
• Report Number: 9612164-2026-02322
• Device Sequence Number: 18746469
• Product Code: NIQ
• UDI-Device Identifier: 00763000511401
• UDI-Public: (01)00763000511401(17)270721(10)0012367347(20)01
• 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
• 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): 07/01/2026

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: ONYXNG27522UX
• Device Catalogue Number: ONYXNG27522UX
• Device Lot Number: 0012367347
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/01/2026; 06/15/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/12/2026; 07/01/2026
• Date Device Manufactured: 07/21/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 103 KG