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

Model Number	ONYXNG25018UX
Medical Device Problem Codes	Deflation Problem (1149); Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	10/01/2024
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 lesion.It was reported that balloon deflation difficulties occurred, and the device would not deflate at the lesion site.A guidewire was used to help dislodge the balloon from the stent, however, in the process the stent moved and had to be retrieved.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: one nc euphora coronary balloon was also being used.The onyx frontier stent was implanted.It was reported that balloon deflation difficulties occurred with the nc euphora balloon, and the device would not deflate at the lesion site.The onyx frontier stent was being post-dilated with the nc euphora balloon mid-stent.One the second post-dilation inflation to 6 atm, the balloon wasn't fully deflated.Negative was pulled.The stent was found in the ulnar artery and was removed by a snare.The nc euphora balloon deflated the first time but did not deflate after the second inflation.The catheter and balloon did not seem to be kinked.The patient was fine and was discharged in the evening.Patient sex and 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
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: the lesion being treated was in the left anterior descending (lad) artery.The nc euphora balloon was inflated, and it appeared that the stent deployed appropriately.When the guidewire was removed the stent was not visible under fluoroscopy.Additional imaging was completed to find the stent, but it was not possible to locate the stent.The patient returned to the inpatient unit where it was identified that the patient's hand was cool and pulseless.The patient was sent to interventional radiology where the stent was found in the ulnar artery and was removed by a snare.Section a.Patient information: patient demographics updated.Correction: annex b 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: 20358105
• Report Number: 9612164-2024-04497
• Device Sequence Number: 8012687
• Product Code: NIQ
• UDI-Device Identifier: 00763000511302
• UDI-Public: 00763000511302
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/13/2024

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 Model Number: ONYXNG25018UX
• Device Catalogue Number: ONYXNG25018UX
• Device Lot Number: 0012313872
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/04/2024; 11/07/2024; 11/12/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/08/2024; 11/13/2024
• Date Device Manufactured: 06/13/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White