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

Model Number	ONYXNG30022UX
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	04/29/2024
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 onyx frontier coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was noted while advancing the device at the lesion site.Excessive force was not used.It was reported that stent deformation occurred in vivo during positioning/advancement.It was also reported that stent dislodgement occurred during removal following a failed delivery.After the delivery system encountered resistance at the lesion site the device was removed and it was noted that the stent was no longer attached to the balloon.Upon angio the stent was seen completely unraveled inside the artery, and was not retrievable.The dislodged stent was not removed and the patient went to surgery to bypass this vessel.The patient is alive with injury.
Additional Manufacturer Narrative
Additional information: the lesion had 80% stenosis.The device was prepped per ifu.Resistance was noted during withdrawal of the device.No excessive force was used.No attempts were made to remove the dislodged stent from the patient due to unravel.Patient sex and gender provided.Correction: the patient is alive with no further injury.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 was pre-dilated with a 2.5 balloon in the mid lad with no issues.The stent got stuck in the mid lad, and unraveling to proximal lad.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: three still images were provided from the facility for analysis.Two pre-treatment images showing contrast injection into the left coronary system.These images appear to show that the vessel tortuosity may have impacted the positioning difficulties with the stent and why the stent dislodged and unraveled.The final image confirms the stent dislodgement and unravelling.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.Kinks were evident on the returned device.The stent was not present on the balloon and did not return for analysis.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.No other damage 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.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: 19268213
• Report Number: 9612164-2024-02187
• Device Sequence Number: 20678535
• Product Code: NIQ
• UDI-Device Identifier: 00763000511494
• UDI-Public: 00763000511494
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup,Followup
• Report Date (Section B): 07/18/2024

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 Model Number: ONYXNG30022UX
• Device Catalogue Number: ONYXNG30022UX
• Device Lot Number: 0012029989
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/28/2024; 05/31/2024; 07/17/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/27/2024; 05/29/2024; 06/06/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male