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

Model Number ONYXNG30038X

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problems Vascular Dissection (3160); Insufficient Information (4580)

Event Date 10/11/2023

Event Type  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.

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a non tortuous, mildly calcified lesion in the distal right coronary artery (rca).One everest inflation device was also used during the procedure.The devices were inspected with no issues noted.The everest device was prepped per ifu with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with a 2.5x15mm semi-compliant balloon.The onyx frontier des 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 the stent balloon diameter of 3.00mm as indicated on the box seemed to be a 3.50mm or 4.00mm diameter.It was detailed that the stent was placed on the 3rd segment of the rca at 9/10atm, below the nominal pressure of 12atm when an adventitious rupture of the wall with stagnation of the contrast product occurred.It is believed that the stent balloon had a diameter greater than 3.00mm.The stent was post dilated.The procedure continued with the placement of two non-medtronic stents upstream.The everest inflation device was used to inflate the onyx frontier des and was also used to correctly inflate the other stents.There were no issues noted when using the everest inflation device.The contrast product stagnation disappeared at the level of the stent implanted in the 3rd segment of the right coronary artery.The echocardiographic control carried out during the procedure did not find any pericardial effusion but a risk of dissection.The adventitial rupture of the rca is limited to this area.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: the patient was hospitalized for a planned angioplasty on the right coronary artery (rca).The 2.5x15mm balloon used for pre-dilation was a non-medtronic device.Correction: a vessel rupture/dissection of the wall occurred after placement of the onyx frontier stent on the 3rd segment of the rca at 9/10atm.There were no inflation difficulties.It is probable that the onyx frontier device caused or contributed to the dissection.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: images confirm the presence of diffuse lesions in the rca.The distal to mid vessel was pre-dilated prior to the delivery and deployment of what appears to be the 3.0 x 38 mm onyx frontier stent.Initial contrast injection into rca shows no evidence of contrast escape from the vessel.But immediately following the image of contrast injection the presence of contrast shadow is evident surrounding the vessel at the location of the deployed stent.Subsequent images appear to show resolution of the contrast leak.The profile of the distal rca vessel appears larger than anticipated post stent deployment.It is not possible to measure the stent od in these 2-dimensional images but the possibility exists that the stent chosen was too large for the chosen vessel.But this cannot be confirmed.The subsequent delivery and deployment of the mid and proximal vessel stents appear to have been completed without issue.Post dilation of the proximal stent was completed prior to completion of treatment.The stent size could not be confirmed from the fluoroscopic images.Product analysis: the onyx frontier delivery system was received for analysis.Kinks were evident on the hypotube.The balloon folds were expanded upon return with contrast visible.The balloon was inflated with no issues noted and the balloon od measured 0.127¿ while inflated to 11.9atm.This determined the od of the balloon was within specification of 0.122" to 0.134¿, as per dimensional specification for a 3.0 x38mm balloon.No other deformation evident to the remainder of the device.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

Additional information: annex d code.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: 18004833
• MDR Text Key: 326511902
• Report Number: 9612164-2023-04863
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG30038X
• Device Catalogue Number: ONYXNG30038X
• Device Lot Number: 0011746505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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 Outcome(s): Other; Required Intervention