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

Model Number	ONYXNG20008UX
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Vascular Dissection (3160); Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent to treat a severely tortuous, mildly calcified lesion with 90% stenosis in the mid/ostium obtuse marginal (om).The device was inspected with no issues.Negative prep was performed with no issues.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. it was reported that stent dislodgement occurred during removal following failed delivery. bifurcation stenting was planned, with the initial stent being placed across the branch in question. once the second wire was replaced, the wire was not through the initial stent, but was outside the stent.The onyx frontier stent was being used as the secondary branch stent.The onyx frontier would not advance because it was behind the initial stent, and when an attempt was made to remove the onyx frontier stent it was pinned and came off of the balloon.A balloon was inserted into the vessel and dilated to crush the dislodged onyx frontier stent in place behind the initial stent.A dissection of the branching artery occurred, which was through the initial stent.The patient is alive with no further 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 stated that the stent became lodged behind the initially placed medtronic stent when trying to remove it.Resistance was noted during withdrawal of the device and excessive force was used.It was confirmed that the dissection occurred during ballooning with a non medtronic balloon and the onyx frontier stent did not cause or contribute to this dissection.The dissection was left alone as it could not be wired properly and instead was treated medically.The initial stent that was implanted was a medtronic stent.There was no damage to this stent as a result of the event.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 summary: the device was returned to medtronic for evaluation.The stent was not present on the balloon and did not return for analysis.Kinks were evident to the hypotube.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.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: 19284558
• Report Number: 9612164-2024-02246
• Device Sequence Number: 7620175
• Product Code: NIQ
• UDI-Device Identifier: 00763000511111
• UDI-Public: 00763000511111
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/20/2024

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: 06/22/2024
• Device Model Number: ONYXNG20008UX
• Device Catalogue Number: ONYXNG20008UX
• Device Lot Number: 0011273653
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 06/17/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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; Other
• Patient Age: 74 YR
• Patient Sex: Male