Medtronic received information via literature regarding the durability of valves following transcatheter aortic valve implantation.All data were collected from a systematic meta-analysis review of 12 studies.The overall study population included 18,814 patients (demographics not provided), an undisclosed number of which were implanted with medtronic corevalve and evolut pro bioprosthetic valves (no serial numbers provided).Among all corevalve patients, adverse events included: need for reintervention, transcatheter valve-in-valve implantation, leaflet calcification, leaflet tear, stent ¿creep¿ (migration), paravalvular leak, patient prosthesis mismatch, and increased mean gradients.Based on the available information, medtronic product may have been associated with the adverse events.Among all evolut pro (corevalve 3rd generation) patients, adverse events included: need for reintervention, leaflet calcification, leaflet tear, stent ¿creep¿ (migration), and unspecified valve issue.Based on the available information, medtronic product may have been associated with the adverse events.Among all corevalve and evolut pro (corevalve 3rd generation) patients, malfunctions included: stent fracture.Based on the available information, medtronic product may have been associated with the malfunction.No additional adverse patient effects or product performance issues were reported.
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