MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 40023 |
Device Problem
Perivalvular Leak (1457)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/15/2021 |
Event Type
Injury
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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.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 post implant of this 23 mm aortic bioprosthetic valve, a post operative echocardiogram was performed which indicated paravalvular leak, as a result the physician chose to put the patient back on pump and attempt to repair it, however the leak remained.Ultimately, the valve was explanted and replaced with a valve of the same size and model.It was reported "patient anatomy could be part of the issue".No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that that the paravalvular leak (pvl) was severe.No additional adverse patient effects were reported. 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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Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve was discolored showing evidence of blood contact with surgical multifilament sutures returned with the valve.The sewing cuff appeared damaged, possibly occurred during explant.All leaflets were severely dehydrated, stiff, and minimally pliable; conditions likely attributed to received condition of the valve.Leaflet 3 (l3) exhibited signs of imprinting from a surgical tool (e.G.: forceps).Leaflets 1 (l1) and 2 (l2) were in the closed position while leaflet 3 (l3) appeared partially open.All posts appeared intact with no signs of deflection.Tissue along the commissures appeared dehydrated, however, intact.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.A conclusive cause of the paravalvular leak (pvl) cannot be determined.Pvl can be caused by a variety of factors, including implant condition/technique, patient anatomy, or presence of pre-existing patient conditions.H3: device evaluated? updated h6: updated the codes 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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