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

Model Number ONYXNG22518UX

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

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 to treat a lesion.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was 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 there were difficulties removing the device following stent deployment.It was detailed that the stent was inserted and deployed successfully but the stent was unable to be removed from the wire.The wire and stent had to be removed together out of the body.The patient is alive with no injury.

Manufacturer Narrative

It was detailed that the stent was inserted and deployed successfully, but the stent delivery system (sds) was unable to be removed from the non-medtronic 180com guidewire post stent deployment.No intervention was required to remove the devices.Resistance was felt when removing the sds over the guidewire to remove the system out of body.No resistance was felt when in coronary artery.The stent was sufficiently expanded prior to attempting removal of the balloon.The guidewire was examined and flushed before use with no issues or kinks noted.There were no difficulties noted when loading the device onto the guidewire.The guidewire was used successfully with other devices prior to the difficulties occurring.There was no damage noted to the guidewire on removal, the guidewire was intact.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.

Manufacturer Narrative

Additional information: annex d codes added.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
• Type of Device: 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: 19061010
• MDR Text Key: 339612449
• Report Number: 9612164-2024-01660
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511210
• UDI-Public: 00763000511210
• 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,Followup
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Model Number: ONYXNG22518UX
• Device Catalogue Number: ONYXNG22518UX
• Device Lot Number: 0011659137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/18/2024
• Date Device Manufactured: 02/28/2023
• 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 Age: 71 YR
• Patient Sex: Male