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

Model Number	ONYXNG25026UX
Medical Device Problem Codes	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	10/08/2024
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
It was reported that during a procedure one 2.5x26mm onyx frontier coronary drug eluting stent dislodged during removal following a failed delivery.The stent was being used to treat a moderately tortuous, severely calcified lesion with 90% stenosis in the distal superior obtuse marginal (om).A 7f guide catheter was engaged in the left main (lm) and multiple non-medtronic guidewires were advanced.The superior om2 branch was pre-dilated serially with a 2.0x20mm euphora balloon.One 2.5x18mm onyx frontier stent was successfully deployed across the lesion.Then the 2.5x26mm onyx frontier was attempted to be advanced but could not be advanced fully to the target lesion, therefore the device was being removed.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.Upon pulling the stent back to the guide catheter the stent dislodged off the balloon into the lm extending into the ostial circumflex (cx) area.Resistance was not felt when pulling back the stent.The dislodged stent was not removed.It was decided that it was safest to deploy the stent at the location of the dislodgement given the amount of calcium and a previous stent that was located in the lm.The dislodged stent was serially dilated with a 1.5x15mm non-medtronic balloon, followed by a 2.0x15mm, 2.5x15mm, 3.5x15mm and a euphora 3.5x12mm balloon.The proximal edge of the stent was further dilated with a 4.0x8mm balloon.Then a 2.5x22mm onyx frontier stent was advanced past the superior om2 stent and placed distally, overlapping the 2.5x26mm onyx frontier stent.Intravascular ultrasound (ivus) was used for vessel and stent assessment.The overlap between the two stents was further post dilated with a euphora 3.5x12mm balloon followed by a 4.5x8mm nc euphora balloon in the proximal edge of the lm-lcx stent.Final angiogram demonstrated excellent angiographic result with timi3 flow, no perforation, no dissection and no residual stenosis.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: there is no complaint against any of the other medtronic devices used during the procedure.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
Procedural image analysis: the target lesion was confirmed to be present in the om of the lcx.The vessel was pre-dilated and what appeared to be the 2.5x18mm onyx frontier stent was successfully deployed across the lesion.The delivery of the 2.5x26mm onyx frontier stent was not provided on the images; however, a dislodged stent can clearly be seen immediately distal to the tip of the guide catheter in the lm.The dislodged stent was sequentially dilated with multiple balloons resulting in stent deployment.A stent was deployed distal to the originally deployed stent.The ostium of the lm to lcx was ballooned with what appeared to be the 4.5 x 8mm nc euphora balloon.The procedural images failed to identify the cause of the dislodgement as it was not captured on the images.A review of the ivus images provided concluded there was moderate calcification present.Double layered struts were shown in a few frames.There was no evidence of significant angiographic complications.A 7f launcher guide catheter was engaged in the left main (lm).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: 20877443
• Report Number: 9612164-2024-05859
• Device Sequence Number: 20796137
• Product Code: NIQ
• UDI-Device Identifier: 00763000511326
• UDI-Public: 00763000511326
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/07/2025

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: ONYXNG25026UX
• Device Catalogue Number: ONYXNG25026UX
• Device Lot Number: 0012357899
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/13/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/12/2024; 02/07/2025
• Date Device Manufactured: 07/14/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG