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

Model Number	ONYXNG25034UX
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure with one onyx frontier coronary drug eluting stent (des), stent deformation occurred in vivo during positioning/advancement, and partial stent dislodgement occurred during removal following failed delivery.It was a difficult complex case.The device was being used to treat a mildly tortuous, moderately calcified lesion with 80% stenosis in the proximal-mid right coronary artery (rca).The patient also had disease in the circumflex artery.The device was inspected prior to use with no issues.Negative prep was not performed.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The stent displacement was noticed while tracking in the vessel and was taken out before the stent came further off the balloon.It was possible to remove the stent as it had only partial dislodged from the balloon and remained on the delivery system.A right radial approach was used.A guide catheter engaged the rca, and a non-medtronic (mdt) wire was advanced down to the distal right posterolateral branch.The lesion was pre-dilated with a 2.5mm balloon.A non-mdt guide extension catheter (gec) was used for support.One 2.5x33mm non-mdt des was placed in the midportion of the vessel overlapping with a 3.0x18mm non-mdt des.The stents were post-dilated with 2.5mm and 3.0mm non-compliant balloons.There was excellent angiographic results with no residual stenosis in the stented area and brisk timi iii flow in the distal vessel.The patient is alive with no 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.
Additional Manufacturer Narrative
Additional information: it was not difficult to remove the stylet or protective sheath before use.Resistance was noted during withdrawal of the device, but excessive force was not used.It was later clarified that there was no movement of the stent off of the balloon.It only became deformed when trying to deliver to the calcified lesion.The stent also failed to cross the lesion.The deformation was noted, and the stent was removed.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.
Additional Manufacturer Narrative
Product analysis summary: the device was returned to medtronic for evaluation.Kinks were evident to the hypotube.The stent was positioned on the balloon between the marker bands as per position specification, but due to mid stent deformation the stent did not meet visual acceptance specification.Deformation was evident to the mid stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a mandrel.No other damage evident to the remainder of the device.Additional information - procedural image review: procedural images were also received.Images provided from the account show the target lesion in the rca and in the lcx.Treatment of the rca was then shown on the images.The proximal rca appeared to be tortuous and the target lesion appeared to exhibit calcification.No images were provided showing the attempted delivery of a stent that was withdrawn without deployment.Therefore, the complaint device does not appear to be captured on the images.The target lesion was pre-dilated followed by deployment of what appeared to be a 33mm stent and then by an 18mm stent proximal to the 33mm stent.These stents were successfully deployed and contrast injection into the rca at the end of the procedure showed good flow through the rca.The tortuosity and calcification in the proximal rca most likely impacted the failure to deliver the medtronic stent but this cannot be confirmed as the medtronic stent was not captured on the images 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.

• 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: 20862336
• Report Number: 9612164-2024-05821
• Device Sequence Number: 15649886
• Product Code: NIQ
• UDI-Device Identifier: 00763000511340
• UDI-Public: 00763000511340
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ONYXNG25034UX
• Device Catalogue Number: ONYXNG25034UX
• Device Lot Number: 0012135246
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 12/20/2024; 01/09/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/11/2024; 01/08/2025; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 80 KG