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); Transient Ischemic Attack (2109); Heart Failure/Congestive Heart Failure (4446)
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Event Date 10/01/2016 |
Event Type
Death
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Manufacturer Narrative
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Age: average.Sex: majority.Outcomes attributed to adverse event, date of event, implant date: estimated.The additional patient effects are filed under a separate medwatch report number.The 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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This research article was a meta-analysis study designed to examine the relation between hemodynamic profiles and outcomes following mitral transcatheter edge-to-edge repair (teer).Complications identified in the study included: death, mitral surgery, heart failure rehospitalization, myocardial infraction, stroke, transient ischemic attack, bleeding.In conclusion, patients undergoing mitral teer, hemodynamic profiling is prognostic, with superior survival occurring among patients with optimal reduction in mitral regurgitation and normal postprocedural left atrial pressure (lap).Details are listed in the attached article titled, "hemodynamic profiles and clinical response to transcatheter mitral repair".
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Manufacturer Narrative
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The products were not returned for analysis.The lot history record (lhr) review and similar complaint review were not performed because this complaint was based on a review article, and no device/lot information was provided.Based on available information and due to the limited information available from the article and the article covering multiple patients, a cause for the reported transient ischemic attack, death /expired, hemorrhage, cerebrovascular accident (stroke), heart failure/congestive heart failure, and myocardial infarction cannot be determined.Transient ischemic attack, death /expired, hemorrhage, cerebrovascular accident (stroke), heart failure/congestive heart failure, and myocardial infarction are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention were 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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