MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number FR995-27 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Endocarditis (1834)
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Event Date 01/27/2024 |
Event Type
Injury
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Event Description
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Medtronic received information that 60 days post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with different manufacturers homograft.The reason for the replacement was reported as endocarditis.The organism cultured was staphylococcus epidermidis.It was also reported that on explant, the patient also had an aortic root abscess.The physician stated that the endocarditis was not a result of the implant procedure, and the valve was not contaminated prior to implant.No additional adverse patient effects were reported.
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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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Manufacturer Narrative
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Event description 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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Medtronic received information that 60 days post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with different manufacturers homograft.The reason for the replacement was reported as endocarditis.The organism cultured was staphylococcus epidermidis.It was also reported that on explant, the patient also had an aortic root abscess.Medication was administered via intravenous piggyback infusion (ivpb) for 6 weeks.The physician stated that the endocarditis was not a result of the implant procedure, and the valve was not contaminated prior to implant.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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