MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-26US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 12/16/2021 |
Event Type
Injury
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, a massive hemorrhage was noted with a decrease of hemoglobin to 8.8 grams per deciliter (g/dl).A blood transfusion was performed.Two months and 19 days following the valve implant procedure, the patient had difficulty breathing and had a medical consultation was done.Hypoxemia was observed and the patient was transferred to a different hospital.Retention of thoracic ascites was noted and the patient was hospitalized due to congestive heart failure.Medication was given.The patient was discharged from the hospital after their condition improved.No additional adverse patient effects were reported.
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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.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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Conclusion: vascular complication, such as bleeding, is a known potential adverse effect per the instructions for use (ifu), and can occur during the implant procedure, with a varying risk that is dependent on several factors such as the access point for the implant, the patient's state of health, and pre-existing medical conditions.The issue is commonly resolved through a blood transfusion or provision of packed red blood cells, as was the case in this event.Heart failure is known potential adverse effects per the device ifu.Unfortunately, a relationship of the reported congestive heart failure to the device or procedure could not be determined with the limited information available, though it is likely related to a patient condition, but a conclusive cause could not be determined from the limited information available.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.This event does not indicate device misuse or malfunction.Updated: h6 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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