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

Model Number	ONYXNG20008UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
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 resolute onyx coronary drug eluting stent and one onyx frontier coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion with 80% stenosis in the distal circumflex (cx) artery and obtuse marginal (om).Both devices were inspected with no issues.Negative prep was not performed on the resolute onyx device.Negative prep was performed with no issues on the onyx frontier device.The lesion was pre-dilated.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the devices.Excessive force was not used during delivery of the devices.It was reported that stent dislodgement occurred during delivery to/at lesion. an attempt was first made to place the resolute onyx stent into the distal om, after pre-dilation, using a non-medtronic guide extension catheter for additional support.The cx was heavily calcified and prevented delivery of the stent to the om.The resolute onyx stent dislodged and was removed from the patient by inflating a 1.25x6mm sprinter balloon into the lumen of the stent and pulling the stent back into the guide, successfully removing it from the body.An attempt was then made to place the onyx frontier stent; however, the same scenario occurred.The same method was used to retrieve the dislodged onyx frontier stent from the patient.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: there were no issues noted with the sprinter balloon used, the balloon was fine.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.
Additional Manufacturer Narrative
Product analysis: the device was received for evaluation.The dislodged stent was received alongside device.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal tip.Deformation was evident to the dislodged stent.Kinks were evident to the hypotube.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: 20123683
• Report Number: 9612164-2024-04014
• Device Sequence Number: 16960250
• Product Code: NIQ
• UDI-Device Identifier: 00763000511111
• UDI-Public: 00763000511111
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/01/2024

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: 05/31/2026
• Device Model Number: ONYXNG20008UX
• Device Catalogue Number: ONYXNG20008UX
• Device Lot Number: 0011794826
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 09/20/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/16/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Sex: Unknown