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

Model Number ONYXNG25015UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 04/12/2024

Event Type  Injury  

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 Description

An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a moderately calcified lesion.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during delivery to the lesion.The dislodged stent was not removed, and was crushed against the wall of the artery.The patient is alive with no further injury reported.

• Brand Name: ONYX FRONTIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 19199677
• MDR Text Key: 341237592
• Report Number: 9612164-2024-02022
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511296
• UDI-Public: 00763000511296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG25015UX
• Device Catalogue Number: ONYXNG25015UX
• Device Lot Number: 0011461306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention