The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported slda, death, cerebrovascular accident, myocardial infarction, tissue injury, and heart failure were unable to be determined.The reported patient effects of cerebrovascular accident, death, myocardial infarction, tissue injury, and heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled "two-year clinical outcome of mitraclip transcatheter edge-to-edge repair from the j-mitra registry data.".
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The article "two-year clinical outcome of mitraclip transcatheter edge-to-edge repair from the j-mitra registry data" was reviewed.The article presented a retrospective multi-center study, to evaluate the 2-year clinical outcomes of all consecutively treated patients who underwent mitraclip implantation in japan and were prospectively enrolled in the j-mitra registry.Devices mentioned include the mitraclip.The article concluded that mitraclip is a viable option with promising clinical outcomes under specific circumstances, even in the context of degenerative mitral regurgitation.[the primary authors were teruhiko imamura, md, phd, second department of internal medicine, university of toyama, toyama, japan; michikazu nakai, phd, clinical research support center, university of miyazaki hospital, miyazaki, japan.The corresponding author was : koichiro kinugawa, md, phd, second department of internal medicine, university of toyama, toyama, japan with corresponding email : kinugawa-tky@umin.Ac.Jp].The time frame of the study was (b)(6) 2020.A total of 2739 patients were included in this study, of which all received an abbott device.The average age of the patients enrolled was 78.The majority gender was male.As this is from a literature review, patient weight was not provided.Comorbidities included: degenerative mitral regurgitation, functional mitral regurgitation, diabetes, myocardial infarction, hypertension, previous percutaneous intervention, previous cardiac surgery, stroke, peripheral vascular disease, chronic pulmonary disease, atrial fibrillation, renal failure, heart failure, cardiac resynchronization therapy, tricuspid regurgitation, heart failure medication.(b)(6) - intra, peri and post-procedural complications included single leaflet device attachment (slda), leaflet damage, cardiovascular death, non-cardiovascular death, heart failure, hospitalization, stroke, myocardial infarction, re-vascularization, surgical intervention (valve replacement), unexpected medical intervention (additional mitraclip).(b)(6) - intra, peri and post-procedural complications included death, atrial septal defect requiring intervention.
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