Citation: hu, j.Md et al.Transcatheter mitral valve implantation for degenerated mitral bioprostheses or failed surgical annuloplasty rings: a systematic review and meta-analysis.Journal of cardiac surgery.Sep;33(9):508-519 epub 2018 jul 10.Doi 10.1111/jocs.13767.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via a meta-analysis literature review regarding the implant of transcatheter bioprosthetic valves implanted into failed mitral valves and rings.All data were collected from a pubmed search of articles published between 2000 and march 2018.Sixty-six articles were identified.The overall population included 245 patients.Eighteen patients were implanted with a melody transcatheter bioprosthetic pulmonary valve, implanted in the mitral position.The remaining patients were implanted with a non-medtronic transcatheter bioprosthetic valve.It was reported that the both mosaic and hancock mitral valves had been replaced during the valve-in-valve implants.Serial numbers were not provided.The study population was predominantly male; mean age 73 ± 12.1 years.Among all patients, no deaths were attributed to a medtronic product.Among all patients implanted with a transcatheter pulmonary valve implanted into the mitral position, adverse events included: valve migration, left ventricular outflow tract (lvot) obstruction, greater than mild mitral regurgitation, blood loss, thrombus, pseudoaneurysm, cerebral vascular accident (cva), arrythmia treated with implantable cardioverter defibrillator (icd), increased mean gradients, leaflet thickening/reduced leaflet motion, and atrial septal defect treated with closure.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.No additional adverse patient effects or product performance issues were reported.
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