Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 04/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The udi number is not known as the part and lot numbers were not provided the additional patient effect of death reported in the article is captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported through a research article that 2,236 patients underwent transcatheter edge-to-edge repair (teer) from (b)(6) 2023.Over several years of the procedure, the implanted mitraclip may have caused or contributed to recurrent mitral regurgitation, bleeding, stroke, myocardial infarction, rehospitalization, and death.Additional information is listed in the attached article, titled ¿transcatheter mitral valve repair with mitraclip: comparison of nt, ntr, and xtr devices.¿.
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Manufacturer Narrative
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B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of death reported in the article is captured under a separate medwatch report.The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported mr, hemorrhage, cerebrovascular accident, myocardial infarction, and death.Mr, hemorrhage, cerebrovascular accident, myocardial infarction, and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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