Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 04/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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One onyx frontier coronary drug eluting stent was implanted in a moderately tortuous, moderately calcified lesion with 90% stenosis in the mid left anterior descending artery (lad).The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a clinical adverse event occurred.It was detailed that the patient suffered an acute stent thrombosis less than 24 hours post stent implantation and vessel occlusion occurred due to the thrombus resulting in slow to no blood flow.The patient is reported to be alive with no injury.
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Manufacturer Narrative
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Image analysis: fluoroscopic image review confirms multiple lesions in the left coronary system.The proximal and mid lad were pre-dilated, followed by deployment of a proximal and mid vessel stent.This stent was post-dilated.The ostial diagonal lesion was pre-dilated and a short stent was deployed in the lesion.The stents appeared to be deployed without issue and the vessel exhibited good patency post stent deployment.Subsequent images appeared to show occlusion to the distal lad.This was further treated with balloon dilations in the lad and diagonal.Additional information: the patient underwent a subsequent percutaneous coronary intervention for post treatment in the cath lab.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.
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Manufacturer Narrative
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Additional information: there were no issues noted during stent deployment, the stent was fully expanded.The patient returned to the cath lab around 1 hour post the original procedure.The thrombus occurred in the lad-diagonal arteries.The patient was on dapt when this thrombotic event occurred.The physician did not assess that the thrombus event was directly related to the use of the relevant device.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.
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Manufacturer Narrative
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Additional information: annex d code.Correction: in order to support root cause determination a medical safety review was performed by a medtronic medical safety specialist.Review confirmed the presence of mild tortuosity and moderate to severe calcification.The wiring and kissing balloon inflation at the lad/d1 appear to be without complications.The stent implantation run could not be observed.A subsequent inflation proximal to the bifurcation was completed which is where it is suspected the stent thrombosis may have occurred.No angiographic complications are noted in the angiograms 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.
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Search Alerts/Recalls
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