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

Model Number ONYXNG27534UX

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 11/13/2023

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

The patient presented to hospital complaining of a few hours of precordial discomfort.On admission the patient was found to have an teroseptal st-segment elevation myocardial infarction.The patient was brought urgently to the cardiac catheterization laboratory for percutaneous transluminal coronary angioplasty.An attempt was made to use one onyx frontier coronary drug eluting stent to treat a severely calcified, severely tortuous lesion with 100% stenosis, located in the distal left anterior descending (lad) artery.Theleft main (lm) artery had 75% stenosis.There was a 90-degree bend from the lm to the lad.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated with a semi compliant balloon.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device failed to cross the lesion and stent dislodgement occurred during removal.It was detailed that a non-medtronic (mdt) guide catheter was used in the right radial artery.After engagement in the lm, the lad was wired with a non-mdt 0.014 guidewire.Over this wire balloon angioplasty was performed with a 2.5x10mm euphora balloon, with multiple inflations, improving flow from timi 0 up to timi 2.The euphora balloon was removed and then attempts were made to pass the onyx frontier device.The stent would not advance from the lm to the lad due to heavy calcium in the distal lm.The stent was removed, and a telescope guide extension catheter (gec) was then placed.Again, attempts were made to pass the stent without success.When the stent was pulled back the stent was stripped off the balloon, due to the marked tortuosity and calcium.Subsequent access was obtained from the right common femoral artery and engaged with the non-mdt guide catheter.Due to the distal lm attempts were not made to re-cannulate this vessel.Peripheral angiography, abdominal aortography, and iliac angiography were performed revealing mild peripheral artery disease (pad) with aortoiliac tortuosity.There was a high bifurcation of the right common femoral artery.An intra-aortic balloon pump (iabp) was th en placed after sizing up to a 9f sheath.This was placed at 1:1 augmentation and sutured in place.The patient was to be transferred to the coronary care unit (ccu) of another facility for potential coronary artery bypass grafting (cabg) surgery.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: there was no resistance noted during attempted withdrawal of the device.The stent remains in the patient.There is no complaint against the euphora device.The telescope device did not cause or contribute to the stent dislodgement in any way.The patient has been discharged.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 codes.Correction: annex e 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: 18211436
• MDR Text Key: 329036923
• Report Number: 9612164-2023-05549
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511432
• UDI-Public: 00763000511432
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG27534UX
• Device Catalogue Number: ONYXNG27534UX
• Device Lot Number: 0011758079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Date Device Manufactured: 05/03/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 85 KG