MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-23US |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422); Low Oxygen Saturation (2477); Low Cardiac Output (2501); Asystole (4442)
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Event Date 01/21/2022 |
Event Type
Death
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Event Description
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Medtronic received information that immediately following the placement of this transcatheter bioprosthetic valve, left bundle branch block (lbbb) and poor extracorporeal membrane oxygenation (ecmo) bleeding were observed.Limited blood flow to the left coronary artery was observed when a contrast study was performed.Coronary artery occlusion due to the valve was suspected. there was little improvement in postoperative cardiac function, therefore an impella cardiac assist device was inserted surgically from the right subclavian artery via cutdown method.Percutaneous coronary intervention (pci) was also attempted, however it was reported it was difficult to engage with the guiding catheter.The left internal thoracic artery/left anterior descending artery were bypassed in accordance with the coronary artery bypass graft (cabg) implementation policy.Afterwards, the physician attempted to withdraw the patient from ecmo, however weaning the patient off was difficult due to a low blood pressure, a low venous oxygen saturation and higher "pa." the heart team determined that circulatory maintenance was difficult due to the effects of the vascular dilatation caused by systemic inflammatory response syndrome (sirs).The patient was concomitantly treated with nicotinamide adenine dinucleotide (nad), however there was no improvement.Due to the limitations of ecmo and continuous hemodiafiltration (chdf), the heart team elected not to perform more circuit replacement or invasive treatment.Fifteen days following the valve implant, the patient developed sustained ventricular tachycardia (vt) and ventricular fibrillation (vf).The patient became asystolic and died.The cause of death was not reported.Per the physician, the reported that the vt/vf/asystole/death were not related to the valve or implant procedure.
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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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Updated section d.4 serial number additional information was received that the impella cardiac assist device was inserted for circulatory support as a treatment for hypotension.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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