Catalog Number UNK CDS |
Device Problems
Off-Label Use (1494); Incomplete Coaptation (2507)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled "same-day discharge following elective transcatheter edge-to-edge repair".Na.
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Event Description
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This research article was a retrospective study designed to evaluate the outcomes after same-day discharge (sdd) in patients who underwent transcatheter edge-to-edge repair (teer).Complications identified in the study included: single leaflet device attachment (slda), life-threatening bleeding, vascular complication, acute kidney injury, mitral or tricuspid reintervention, readmission due to heart failure, and all-cause mortality.In conclusion, in this single-center retrospective analysis, sdd after teer was feasible with comparable safety outcomes with non-sdd.Patients undergoing isolated tteer, combined mitral and tricuspid teer, or afternoon procedures were more likely to have a delayed discharge (>1 day).As teer continues to become widely adopted, the sdd pathway is likely to be more commonly implemented.A larger prospective study is ongoing to further evaluate the safety and efficacy of the sdd approach.Details are listed in the attached article titled, "same-day discharge following elective transcatheter edge-to-edge repair".
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Manufacturer Narrative
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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 hemorrhage, renal failure, heart failure, and death.Hemorrhage, renal failure, heart failure, and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical interventions were results of case specific circumstances.The reported off-label use was due to the device being used on a tricuspid valve.There is no indication of a product issue with respect to manufacture, design, or labeling.Literature attachment: article title "same-day discharge following elective transcatheter edge-to-edge repair".
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Search Alerts/Recalls
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