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

Model Number	ONYXNG27522UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a mildly tortuous, mildly calcified lesion with 90% stenosis in the proximal diagonal.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during removal following a failed delivery.It was stated that the dislodged stent came out and was located in the touhey.The dislodged stent was removed.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: the device was prepped per ifu with no issues noted.Resistance was noted during withdrawal of the device, but excessive force was not used.The dislodged stent was found in the touhey portion of the delivery equipment.During this interventional procedure a 6f system was being used, and multiple types of equipment were being utilized via this system (one stent and two balloons).It is believed that some entanglement may have occurred which contributed to the stent dislodgement, and it was stated that a 7f system may have been more optimal for this intervention.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: no intervention was required to remove the dislodged stent.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.

• 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: 19069059
• Report Number: 9612164-2024-01663
• Device Sequence Number: 20016763
• Product Code: NIQ
• UDI-Device Identifier: 00763000511401
• UDI-Public: 00763000511401
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/02/2024

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 Expiration Date: 07/15/2026
• Device Model Number: ONYXNG27522UX
• Device Catalogue Number: ONYXNG27522UX
• Device Lot Number: 0011868396
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 04/16/2024; 04/24/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/12/2024; 04/23/2024; 05/02/2024
• Date Device Manufactured: 07/16/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 92 KG