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

Model Number ONYXNG35038X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

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 noted.Negative prep was performed with no issues noted.It was reported that there were balloon deflation difficulties and the balloon would not deflate at the lesion site.It was detailed that following stent implantation, it was impossible to retract the balloon within the guide catheter.The balloon was removed with the catheter/guidewire system however the position of the guidewire was lost at the peripheral zone of the coronary artery.It was necessary to change the guide catheter and reposition the guidewire laterally to the stent previously implanted and implant another stent-in-stent in order to optimize the intravascular ultrasound (ivus) guided procedure on the left main coronary artery (lm)/left anterior descending (lad).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: no difficulties were noted when removing the protective sheath/packaging stylette from the device.The concentration of contrast used was standard, approximately 30-40% contrast to 60-70% saline.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not noted while advancing the device to the lesion.The device was moved or repositioned in the lesion.No difficulties were noted during inflation of the device.Deflation difficulties were noted after the first and only inflation.It was detailed that initially the balloon did not deflate after multiple deflation attempts with the same indeflator.The indeflator was changed and deflation was attempted multiple times with no success.The deflation was determined to be slow.After roughly 30 seconds the balloon deflated a little however the balloon remained inflated at 60% in the aorta.It was possible to remove the balloon from inside the stent.No intervention was required to remove the device from the patient.There was no physical damage to the patient however the proximal edge of the stent had to be crushed and a second medtronic stent was implanted at the ostium-shaft-bifurcation in the second segment of the left main.Guide catheters and guidewire used during the procedure were non-medtronic.Initial reporter phone # and email address.Image analysis: a sixteen-second video was received from the account for review.Four still images were taken from this video for review.Image one shows a non-medtronic guide catheter with the distal section of the frontier device protruding from the distal tip.A guidewire is also visible protruding from the distal tip of the frontier device.The distal section of the balloon appears to be partially inflated.Blood is visible on the balloon.Image two shows a pulling force has been applied and the user is attempting to pull the frontier device through the guide catheter.The proximal section of the balloon has successfully entered the guide catheter.The distal section of the frontier device protrudes from the distal tip.A guidewire is also visible protruding from the distal tip of the frontier device.The distal section of the balloon appears to be partially inflated.Blood is visible on the balloon.Image three shows the very distal section of the frontier device protruding from the distal tip.A guidewire is also visible protruding from the distal tip of the frontier device.The distal section of the balloon appears to be partially inflated.Blood is visible on the balloon.Image four shows the user has attempted to pull the frontier device through the guide catheter unsuccessfully.The inflated distal section of the device remains outside the guide catheter.Product analysis: the device was received for analysis.The frontier delivery system returned loaded through a non-mdt guide catheter and a non-mdt y- connecter was attached to the guide catheter.Kinks were evident on the hypotube.The distal section of the balloon was noted to be protruding from the tip of the guide catheter and appeared bunched.It was not possible to remove the balloon from the guide catheter however it was possible to advance the frontier distally to allow for further examination.It was then noted that the exchange joint and the length of the distal shaft was bunched and kinked.The core wire was kinked, and it had also torn and was protruding through the outer shaft.Blood was visible within the inflation lumen as a result.Proximal of the balloon the inflation lumen/balloon bond was necked and bunched.The balloon folds appeared partially inflated with crystallised contrast visible within.Again the distal section of the balloon was noted to be bunched.The balloon failed negative prep due to the torn outer shaft.It was not possible to preform deflation testing due to the condition 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.

• 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: 18373031
• MDR Text Key: 331108599
• Report Number: 9612164-2023-06142
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG35038X
• Device Catalogue Number: ONYXNG35038X
• Device Lot Number: 0011862714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Date Device Manufactured: 07/11/2023
• 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): Required Intervention