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

Model Number	ONYXNG40012UX
Medical Device Problem Codes	Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion with 90% stenosis in the mid circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with a 4.0mm non-medtronic intravascular lithotripsy (ivl) balloon and a 2.5mm balloon.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.It was reported that the balloon failed to expand under the stent.It was detailed that at first a longer stent was attempted to be used but was unable to cross the lesion.Therefore, two shorter stents were to be used.The onyx frontier stent was the first stent to be placed but during deployment the distal part of the stent deployed, but the balloon would not fully inflate at the proximal end.It was stated that it was like the balloon had ruptured.The non-medtronic inflation device was evaluated and tried multiple tim es with no success.The stent balloon was removed, and other balloons were used to inflate the stent to a fully opposed level within the artery with no issues.The stent balloon was evaluated once removed and the balloon worked.No rupture was reported.The patient is alive with no further 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
Additional information: 14 atm of inflation pressure was applied.The inflation device was successfully used with other balloons.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 returned with balloon folds expanded.There was no evidence of necking on the proximal balloon bond/distal inflation lumen.The balloon passed negative prep.The balloon was inflated to 12 atm and maintained pressure.The balloon deflated with no issues noted.No other deformation evident to the remainder of the 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.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: 19085928
• Report Number: 9612164-2024-01721
• Device Sequence Number: 17927316
• Product Code: NIQ
• UDI-Device Identifier: 00763000511647
• UDI-Public: 00763000511647
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/08/2024

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 Expiration Date: 06/07/2026
• Device Model Number: ONYXNG40012UX
• Device Catalogue Number: ONYXNG40012UX
• Device Lot Number: 0011810495
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided; 04/22/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/19/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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 Sex: Male