Medtronic received information that 3 years post implant of this 19mm bioprosthetic aortic valve, it was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for replacement was reported as a base pseudoaneurysm with moderate-severe aortic regurgitation.It was also suspected that the patient may have had an infection approximately 1 year prior to the replacement, although this was not confirmed with in-hospital examinations.No additional adverse patient effects were reported.
|
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the sewing ring was removed, partially exposing the stent.Tears on the right cusp outflow rail were noted.The valve appeared distorted, slightly oval-shaped.All leaflets are stiff but slightly flexible in areas with no visible calcification.Calcification was observed on all leaflets appearing to contribute to the tissue deterioration of all cusps.The non-coronary cusp appeared to be in the closed position.Severe tissue deterioration on the right cusp and left cusp created a large central gap.Tissue deterioration due to calcification was observed on all commissures.Traces of pannus were observed on the right cusp outflow rail approaching the left/right commissure.An unknown amount of pannus may have been removed during explant.Radiography revealed calcification on the returned valve.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.The reported regurgitation appears to be consistent with the risk analysis and historical trend with the confirmed calcification being a common cause.Calcification is an inherent risk of bioprosthetic valve replacement and can be a patient-related condition.From the available information, a conclusive cause of the dissection and pseudoaneurysm could not be determined.A pseudoaneurysm can occur due to user technique and/or patient-related factors.D2: product code updated.D9: device available for evaluation? updated.H3: device evaluated? updated.H6: coding updated.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.
|