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

Model Number	ONYXNG20026UX
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: it was later stated that it is believed that that the reason for stent dislodgment was likely due to the stent catching on a previous stent.Resistance was noted during withdrawal of the device and force was noted.The stent that was deployed in order to crush the dislodged stent was a medtronic stent and there were no issues noted with it when crushing the dislodged stent.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: it was believed that there was not a defect with the stent itself and it simply got caught on the previous stent and/or tavr valve.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
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 in the mid left main (lm) coronary artery.The patient had tortuous vessels.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not device pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during removal following failed delivery. the dislodged stent was not removed.After review of the procedural films, it seems likely that the stent caught on the previously implanted medtronic tavr valve, or on the previously implanted proximal lad stent when the delivery system was attempted to pass through previous stent.The stent would not cross, was pulled back and dislodged in the lm. the stent was crushed in the lm with an additional stent.The patient is alive with no further injury.

• 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: 19391297
• Report Number: 9612164-2024-02524
• Device Sequence Number: 15216169
• Product Code: NIQ
• UDI-Device Identifier: 00763000511166
• UDI-Public: 00763000511166
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/09/2024

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: 04/24/2026
• Device Model Number: ONYXNG20026UX
• Device Catalogue Number: ONYXNG20026UX
• Device Lot Number: 0011746994
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 06/27/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/12/2024; 07/09/2024
• Date Device Manufactured: 04/25/2023
• 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: Female