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

Model Number	ONYXNG27538UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
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 lesion.It was reported that stent dislodgement occurred in vivo during delivery to the lesion.The dislodged stent was removed using a snare.No further patient injury was reported.
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
Product analysis: the device was returned for analysis.A kink was evident to the hypo-tube.The stent was not present on the balloon and did not return for analysis.The balloon folds were partially expanded.It was not possible to confirm the presence of crimp impressions due to the open balloon folds.No other damage evident to the remainder of the device.Correction: h.8.Usage of 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: 19031398
• Report Number: 9612164-2024-01566
• Device Sequence Number: 15214309
• Product Code: NIQ
• UDI-Device Identifier: 00763000511449
• UDI-Public: 00763000511449
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: ONYXNG27538UX
• Device Catalogue Number: ONYXNG27538UX
• Device Lot Number: 0012053270
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2023
• 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 Sex: Unknown