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

Model Number	ONYXNG22518UX
Medical Device Problem Codes	Entrapment of Device (1212); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	08/08/2024
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 non-tortuous, moderately calcified lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did 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 delivery to/at the lesion.An attempt was made to deliver the 2.25 x 18 onyx frontier stent to the mid lad and the diagonal bifurcation, but friction was felt when the stent passed through the previously implanted stent (from 2019).During attempts to withdraw the stent delivery system, there was resistance felt.Upon removal of delivery system, the balloon was inspected and the stent was not present.Under flouro, the stent was seen to have dislodged in the mid lad.It was then attempted to deliver a balloon to crush stent against vessel wall but was unsuccessful in delivering the balloon.The stent was not removed from the patient.The patient reported to be stable and was transferred to another hospital for further evaluation and to consider possible percutaneous removal or coronary artery bypass graft (cabg) if necessary.It was stated that this was a complex case in which it was attempted to stent the lad and diagonal bifurcation in the culotte method.The previously stented area from 2019 had two layers of stent as well as some in stent restenosis.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: the lesion had 70-80% stenosis.During attempts to withdraw the stent delivery system there was resistance felt, but the device was not yanked on or pulled with excessive force.Numerous attempts were made to wire around the undeployed stent to deliver a balloon and crush the stent however it was not able to adequately deliver equipment beside the stent.The undeployed stent did not move after it came off the delivery system.The dislodged stent got caught on the prior stents already deployed in the vessel, and was stuck on those stents, which is how the dislodged onyx frontier remained in place.The previously implanted stents were non-medtronic devices.There was no damage to these previous stents documented as a result of the event.Initial reporter's phone number provided.Patient gender provided.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: annex d code.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: 20001992
• Report Number: 9612164-2024-03738
• Device Sequence Number: 4953671
• Product Code: NIQ
• UDI-Device Identifier: 00763000511210
• UDI-Public: 00763000511210
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/09/2024

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: 05/30/2026
• Device Model Number: ONYXNG22518UX
• Device Catalogue Number: ONYXNG22518UX
• Device Lot Number: 0011800235
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 09/04/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/30/2024; 09/09/2024
• Date Device Manufactured: 05/31/2023
• 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: 75 YR
• Patient Sex: Male