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

Model Number	ONYXNG30034UX
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Vascular Dissection (3160); Insufficient Information (4580)
Date of Event	02/15/2024
Type of Reportable Event	Serious 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.
Event or Problem Description
An attempt was made to use one 3.0 x 34mm onyx frontier drug eluting stent to treat a lesion.It was stated that 3.0 x 34mm was indicated on the box, package and stent delivery device hub.It was reported that when the stent balloon was inflated to 14 atm for 21 seconds, the balloon appeared larger than the expected 3.0mm.Intravascular ultrasound measured the balloon expanded stent at 3.5 mm.A distal stent edge dissection was also noted which required addition stenting.No further patient injury was reported.
Additional Manufacturer Narrative
Additional information: an attempt was made to use one 3.0 x 34mm onyx frontier drug eluting stent to treat a non-calcified, non-tortuous lesion with 80% stenosis in the mid left anterior descending artery (lad).The device was inspected before use with no issues noted.The lesion was pre-dilated with a 2.0 and 2.5 nc euphora balloon.Resistance was not noted when advancing the device to the lesion.The onyx frontier was successfully implanted in the patient.It is believed that the dissection was caused by the onyx frontier.The additional stent was placed at the dissection edge.The same inflation device was successfully used with other devices.The patient is following up with another clinic.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
Regulatory report 9612164-2024-02897 aware date is (b)(6) 2024.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: 19566552
• Report Number: 9612164-2024-02897
• Device Sequence Number: 7097324
• Product Code: NIQ
• UDI-Device Identifier: 00763000511524
• UDI-Public: 00763000511524
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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: 09/30/2026
• Device Model Number: ONYXNG30034UX
• Device Catalogue Number: ONYXNG30034UX
• Device Lot Number: 0011976453
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 08/14/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/11/2024; 08/15/2024
• Date Device Manufactured: 10/01/2023
• 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 Age: 85 YR
• Patient Sex: Male