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

Model Number	ONYXNG30022UX
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Arrhythmia (1721); Ischemia (1942); Myocardial Infarction (1969); Shock (2072); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	12/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a severely calcified, severely tortuous lesion in the proximal left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.It was reported that there was balloon removal difficulties after stent deployment, and a catheter shaft break occurred.The circumflex artery had been successfully stented with two non-medtronic (mdt) des.The lad was calcified and shockwave lithotripsy was done.There was difficulty in removing the lithotripsy system.The mid lad was stented with a non-mdt des.The proximal lad was then stented with the onyx frontier des.Post stent placement the onyx frontier balloon appeared stretched out and would not retract.Attempts were made to remove the stent catheter with a non-mdt guide extension catheter, but the catheter presumably broke, as the balloon appeared caught on the stent scaffold.The lad became occluded by the catheter/balloon and the patient became severely ischemic.It was intended to transfer the patient to another facility but the patient expired prior to the transfer.
Additional Manufacturer Narrative
Image analysis: two photos of what appears to be the distal end of the delivery system with debris covering the distal end of the catheter, contained in a specimen container were provided.In addition, a photo confirming the product identification was provided.Additional information: the patient had severe calcification of main coronary arteries with diffuse triple vessel disease observed.The catheter got stuck in the vessel and broke in half.There was no evidence of thrombus.The physician assessed that the death event was directly related to the use of the relevant device.Cause of death was device occlusion of the lad resulting in decreases in typical indices (cardiac output, heart rate, blood pressure), as well as subsequent changes in cardiac rhythm.Infarction of the anterior wall of the left ventricle, as evidenced by precordial st-elevation on surface ecg, was noted consequential of severe ischemia of the lad artery.Official cause of death is; cardiogenic shock, acute coronary artery syndrome, severe three vessel coronary artery disease and end stage renal disease.Lot number provided.Additional past medical history provided.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.
Additional 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
• Common Device Name: 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: 16109527
• Report Number: 9612164-2023-00070
• Device Sequence Number: 2009145
• Product Code: NIQ
• UDI-Device Identifier: 00763000511494
• UDI-Public: 00763000511494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: ONYXNG30022UX
• Device Catalogue Number: ONYXNG30022UX
• Device Lot Number: 0011039027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 04/14/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/08/2023; 04/18/2023
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male