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

Model Number ONYXNG22515X

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

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/23/2024

Event Type  Injury  

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 three onyx frontier coronary drug eluting stents to treat a lesion in the left anterior descending (lad) artery and left circumflex (lcx) artery.It was reported that a clinical adverse event occurred.It was detailed that the patient suffered an acute stent thrombosis 0-24 hours post stent implantation.It was detailed that the patient presented to hospital with chest discomfort and a history of dyspnea on exertion.An echocardiogram showed adequate left ventricle (lv) function and blood investigation showed anemia and hyperglycemia.A coronary angiogram revealed critical lad and lcx disease.A percutaneous coronary intervention (pci) was performed.The following day an angiogram revealed patient stents and no thrombus.The patient was treated with anticoagulants, antiplatelets, statin, antihypertensive, antianginal, steroid, proton pump inhibitors (ppis) and other supportive measures.The patient improved and was discharged in a stable status.There was no further patient injury reported.

Manufacturer Narrative

Additional information: it was later confirmed that the three onyx frontier stents were implanted in the lad.The devices were inspected before use with no issues noted.The lesion was pre-dilated.Resistance was not noted when advancing the devices to the lesion and excessive force was not used.The thrombus occurred immediately post procedure after the wire was taken out.The thrombus occurred in the mid and distal part of two of the lad stents (b)(6) and (b)(6)).A vessel dissection also occurred in the distal lad stent section with the(b)(6) stent.The thrombus was treated with post dilation with a non medtronic non compliant balloon with no issues.During the procedure all required medicines given as per prescribed dose.It was stated that it was not known if the thrombus event was directly related to the use of the medtronic devices as it occurred immediately post procedure.The patient had no specific history related to the thrombotic event.The patient is reported to be fine.Correction: fdm 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.

Manufacturer Narrative

Additional information: the stents were fully expanded in the vessel.No thrombus or dissection occurred and there were no issues noted with the third stent used, onyxng20015x.The dissection was treated with an overlapping stent.During the procedure all anti coagulants and anti platelet drugs was given as per prescribed dose.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: 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: 19173014
• MDR Text Key: 340928850
• Report Number: 9612164-2024-01972
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONYXNG22515X
• Device Catalogue Number: ONYXNG22515X
• Device Lot Number: 0012001455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Date Device Manufactured: 10/18/2023
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Female