It was reported through a research article that 100 patients underwent transcatheter edge-to-edge repair (teer) from (b)(6) 2020 to (b)(6) 2021.Within one year of the procedure, the implanted mitraclip may have caused or contributed to mitral stenosis, tamponade, and heart failure hospitalization (hfh).Additional information is listed in the attached article, titled ¿mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.¿.
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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 heart failure, tamponade, and mitral stenosis were unable to be determined.The reported patient effects of mitral stenosis, cardiac tamponade, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and serious injury/ illness/ impairment were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B3: date of event estimated d4: the udi is unknown due to the part/lot number was not provided d6: date of implant estimated attachment: article titled ¿mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.
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