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

Model Number ONYXNG35022X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/20/2024

Event Type  Death  

Manufacturer Narrative

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.

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a moderately tortuous, moderately calcified lesion in the left anterior descending (lad) artery.There was in-stent restenosis (isr) in the vessel.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that stent thrombosis occurred, followed by vessel occlusion due to the thrombus, and death occurred.The lad had isr from a previous stent.Laser was used on the isr.It was detailed that the mid to proximal lad was stented.The 3.5x22mm onyx frontier des was placed in the proximal lad.Also, the ostial to proximal circumflex (cx) artery was stented.Upon completing the percutaneous coronary intervention (pci) of the lad and the cx, the right coronary artery (rca) was cannulated with a guide.The rca was wired and ballooned with a 4.0x20mm compliant balloon.After ballooning the rca, the patient's hemodynamics changed, and angiography showed the rca was dissected.Two 3.5x38mm onyx frontier stents were placed from the distal to proximal rca, and then one 3.5 x18mm onyx frontier des was placed in the proximal to ostial rca.A code was called as patient's vitals continued to deteriorate.The left main (lm) was re-cannulated, and the 3.5x22mm onyx frontier des in the proximal lad had re-stenoses with a fresh clot, which stopped perfusion of the heart.It is unknown if the onyx frontier stent was correlated with the re-stenoses and fresh clot.There could have been a number of things which cause the event, but it is believed that the re-stenoses in the lad is what caused the patient to pass.

Manufacturer Narrative

Additional information: the 3.5x22mm onyx frontier des was being used to treat the isr.There was no issue noted during the 3.5x22mm onyx frontier des deployment in the proximal lad.Intravascular ultrasound (ivus) was used both pre and post deployment, and the stent was fully expanded.The 4.0x20mm compliant balloon used was a non-medtronic device.Heparin was administered during the intervention.The cause of death is the fresh clot and re-stenosis in the lad stent.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.

Manufacturer Narrative

Additional information: annex d code.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: 19039664
• MDR Text Key: 339319547
• Report Number: 9612164-2024-01591
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONYXNG35022X
• Device Catalogue Number: ONYXNG35022X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• 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): Death; Required Intervention
• Patient Sex: Female