As reported, approximately 1 year, 7 months post tf tavr the patient was admitted with what is probable severe para-valvular leak causing hemolysis.The patient received an 8mm avp ii vascular plug thus resolving the pv leak.The patient left the room in stable condition.
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Updated h.6 codes.The device was not returned for evaluation.A dhr review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.During manufacturing of the sapien 3 ultra transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The ifu was reviewed.Long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Paravalvular or transvalvular leak, valve regurgitation, and hemolysis are all listed as potential risks associated with the use of the valve, delivery system, and/or accessories.No ifu/training deficiencies were identified.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.The paravalvular leak was unable to be confirmed due to unavailable of relevant medical record/ imagery.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.A review of ifu/training materials revealed no deficiencies.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Due to limited information, a definitive root cause for severe pvl approximately 1 year and 7 months post tavr was unable to be determined at this time.
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