Model Number ONYXNG20015X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 03/23/2024 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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 (onyxng22515x and onyxng25030x).A vessel dissection also occurred in the distal lad stent section with the onyxng25030x 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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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