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

Model Number ONYXNG20030UX

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Dyspnea (1816); Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Injury  

Event Description

An onyx frontier coronary drug eluting stent (des) was implanted during an index procedure in a moderately tortuous lesion in the distal left anterior descending (lad) artery.During the procedure three other onyx frontier des were implanted, one in the mid lad, one in the proximal lad and one in the proximal first diagonal.A 2.25x20mm nc euphora balloon was also used during the index procedure.A right radial access was used.The onyx frontier implanted in the distal lad was inspected prior to use with no issues noted.Negative prep was not performed.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.The stent was deployed to 12 atm for 16 seconds.The distal lad was post-dilated with a balloon to 16 atm for 15 seconds, and 12 atm for 5 seconds.There were no procedure al complications.No other medtronic devices were used during the index procedure.It was reported that approximately four months later the patient presented with symptoms of chest pain and shortness of breath.During an angiogram of the left system, it was noted that the distal onyx frontier stent was severely fractured.The fractured stent was not ballooned, and a new stent was not placed.Instead, medical management and clinic follow-up to monitor the patient is planned.The patient is alive with no further injury.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis: a three second video image was provided for review.The video showed that there were previously deployed stents in the lad.Contrast injection into the left coronary system shows that the flow to the distal vessel through the distal stent appears to be restricted.The final image appears to show in-stent restenosis (isr) in the distal stent.There is no clear evidence of a stent fracture.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18333663
• MDR Text Key: 330544914
• Report Number: 9612164-2023-05991
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511173
• UDI-Public: 00763000511173
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG20030UX
• Device Catalogue Number: ONYXNG20030UX
• Device Lot Number: 0011476944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Date Device Manufactured: 11/02/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White