Medtronic received information via literature regarding a 64-year-old male patient who developed mixed aortic stenosis/regurgitation and underwent transcatheter aortic valve replacement (tavr) using a 34-mm medtronic evolut r bioprosthetic valve (unique device identifier number not provided).The patient had chronic obstructive pulmonary disease (copd) from alpha-1-antitrypsin deficiency and underwent double-lung transplantation per median sternotomy one year post-tavr.Approximately one year post-lung-transplantation, a chest computerized tomography (ct) scan detected a mediastinal hematoma, though the patient was asymptomatic.A chest ct angiogram revealed an ascending aortic pseudoaneurysm at the tavr valve, extending into the hematoma.The patient was hospitalized and underwent emergent surgical repair.It was discovered the evolut r valve struts extended into the pseudoaneurysm sac and through the aortic wall with the sac being filled with organized thrombus.The valve was replaced with a non-medtronic bioprosthetic valve.The authors noted the likely etiology of the pseudoaneurysm was friction between the valve, aortic wall and sternal wiring from the prior sternotomy.No additional adverse patient effects or product performance issues were reported.
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Citation: cai x.; et al.Ascending aortic pseudoaneurysm: a rare complication of transcatheter aortic valve replacement and thoracic surgery.Circ cardiovasc imaging.2022 jul;15(7):e014076.Doi: 10.1161/circimaging.122.014076.Epub 2022 jul 23.Pmid: (b)(4) earliest date of publication used for date of event.Medtronic products referenced: evolut r (pma# p130021, product code: npt).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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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