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

Model Number ONYXNG25022UX

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 02/21/2023

Event Type  malfunction  

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.

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion with 80% stenosis in the proximal diagonal branch.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The device was not kinked and re-straightened during use.It was reported that the catheter/shaft fractured during delivery through the vessel.It was stated that the catheter fractured outside of the body.The detached portion of the device does not remain in the patient.The patient is reported to be alive with no injury.

Manufacturer Narrative

Product analysis: the device was received for analysis.The device returned with a detachment on the hypotube.Kinks were evident on the hypotube, proximal and distal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.The stent was positioned on the balloon between the marker bands as per specifications.No deformation evident to stent wraps.A tear was evident to the distal tip.The inner lumen patency was verified with a 0.015-inch mandrel.No other damage was evident to the remainder of the device.Additional information: the catheter fracture occurred outside of the body.The detached portion was pulled out by hand and successfully removed from the patient.Initial reporter phone number updated.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: image confirmed the presence of multiple lesions in the left coronary system with three (3) wires delivered to the vessels.Pre-dilation was completed prior to stent deployment, followed by post dilation activities, further stent deployments and further post dilation of the stents and the vessels.There were no images showing the delivery of a stent that was not deployed, although there were two long gaps in the images where the possibility exists the shaft breakage event may have occurred.But this cannot be confirmed from the images.Given the multiple lesions in the vessels, the use of a guide extension catheter (gec) for catheter delivery and the multiple pre- and post-dilations that were necessary to prepare the vessels and to fully expand the stents suggests that the vessel morphology may have impacted on the product issues.But this cannot be confirmed.Annex d codes.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: 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: 16477147
• MDR Text Key: 310610737
• Report Number: 9612164-2023-00963
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511319
• UDI-Public: 00763000511319
• 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,Followup
• Report Date: 05/02/2023

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: ONYXNG25022UX
• Device Catalogue Number: ONYXNG25022UX
• Device Lot Number: 0011500818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/09/2023; 04/27/2023
• Supplement Dates FDA Received: 04/03/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 74 KG