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

Model Number ONYXNG27522UX

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Non specific EKG/ECG Changes (1817); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat, moderately calcified, severely tortuous lesions in the proximal and distal right coronary artery (rca).The right coronary artery (rca) was described as having a shepard's crook and a previously implanted des, with proximal and distal edge stenosis.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with one 2.5x15mm non-mdt balloon and two 2.5x15mm sc euphora balloon catheters.The onyx frontier device did pass through a previously-deployed stent.Resistance was encountered when advancing the onyx frontier device.Excessive force was not used.A 6fr launcher guide catheter was also used.It was reported that during pre-dilation the balloons had difficulty crossing the lesion.After pre-dilation the onyx device was advanced but failed to cross the pre-existing proximal des and was removed.Additional pre-dilations x3 were carried out and a 6fr non-mdt guide extension catheter was used to pass the onyx frontier to the posterior descending artery (pda).The onyx frontier crossed the lesion but only 12mm of the 22mm looked deployed in the distal rca with 8/10/12 atm of pressure.Contrast was visualized sitting/stagnating in balloon.The inflation device was disconnected and re-filled with fluid to ensure this was not the issue and was reattached.8/12 atm was then applied but again only 12mm of the onyx device looked deployed.It was reported that a leak/burst was observed and the onyx frontier device was removed.It was suggested that the previously deployed stent in the proximal lesion may have damaged the onyx frontier balloon device, which was detailed to have a pinhole.It was stated that the device would not deflate at the lesion site and there was difficulty removing the balloon following balloon inflation.Two sc euphora balloon catheters (2.5x20mm and 2.75x20mm) were then advanced and used with great results.The patient's sts resolved and the physician stented the distal pre-existing des with a different onyx frontier (onyxng3015) without issue and with great result.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

Additional information: it was stated that the device would not maintain 8-10 atm of pressure.The device was not moved or repositioned in the lesion while inflated.It was stated that the device deflated slowly at the lesion site over a few seconds, with residual contrast in the balloon.The slow deflation time was deemed clinically insignificant.The deflated onyx frontier balloon was removed from the stent and out of the patient and guide without issue.The guidewire was maintained distally.Intervention was not required to remove the device.Two sc euphora balloon catheters (2.5x20mm and 2.75x20mm) were then advanced and used to post dilate the onyx frontier stent using 8/12 atms of pressure with great results.There is no complaint against the launcher guide catheter or the two 2.5x20mm and 2.75x20mm sc euphora balloons used.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

Product analysis summary: the device returned with a stopcock loaded and it was removed with no issues noted.Blood was visible in the stopcock and leur.The device returned with proximal balloon folds partially expanded.Mid to distal balloon folds remained intact.Blood was visible in the balloon and inflation lumen.Crimp impressions were visible on the exposed balloon surface.There were no issues noted with the proximal balloon bond.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon working length over the distal marker band.The balloon failed to maintain pressure.Upon visual inspection of the device, a radial tear was observed over the distal marker band.No deformation evident to the distal tip.No other damage 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: a omnipaque 50% /heparinized saline 50% concentration of contrast / saline was used.The patient had st segment elevation in the ekg leads which resolved after a short duration, and was deemed clinically insignificant by the physician.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

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).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: 15011169
• MDR Text Key: 304625156
• Report Number: 9612164-2022-02652
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511401
• UDI-Public: 00763000511401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043/S055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: ONYXNG27522UX
• Device Catalogue Number: ONYXNG27522UX
• Device Lot Number: 0011088549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 95 KG