B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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The article, "clinical impact of patient-prosthesis mismatch after aortic valve replacement with a mechanical or biological prosthesis", was reviewed.The article presented a prospective, single center study to investigate the impact of patient-prosthesis mismatch (ppm) on long-term survival and quality of life after mechanical and biological aortic valve replacement.Devices included in this study were sjm masters, sjm regent, medtronic ats open pivot, cyrolife on-x, livanova carbomedics, medtronic hancock ii, abbott epic, abbott trifecta gt, livanova crown prt, livanova solosmart, and livanova perceval s.The article concluded mismatch is common after biological valve implantation and statistically significantly affects long-term survival and quality of life.If the risk of ppm after implantation of a biological prosthesis is suspected, adopting strategies to avoid ppm at the time of surgery is warranted.[the primary and corresponding author was (b)(6).
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