EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
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Model Number 9600TFX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemolysis (1886)
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Event Type
Injury
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Event Description
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As reported through an article, 'hemolysis after transcatheter mitral valve replacement in degenerated bioprostheses, annuloplasty rings, and mitral annular calcification: incidence, patient characteristics, and clinical outcomes', a single center retrospective review of clinical outcomes and optimal management for patients with hemolysis after transcatheter mitral valve replacement tmvr was performed.Tmvr procedures were performed between january 2014 and february 2020.A total of 101 tmvr patients were assessed, including 69 with mviv, 14 with mvir, and 18 with vimac.Vimac patients had an increased frequency of mild or greater paravalvular leak (pvl) (vimac, 72.2%; mvir, 14.3%; mviv, 13.0%; p <.001).Hemolysis occurred in eight patients and was more common after vimac (vimac, 33.3%; mvir, 7.1%; mviv, 1.5%; p <.001).This required transfusion in five (vimac, 4; mviv, 1) and was associated with acute kidney injury in five with vimac.Among the vimac patients, four had transcatheter re-intervention to treat hemolysis with resolution of anemia in three and mild residual anemia in one with persistent mild pvl.The two vimac patients without re-intervention had persistent anemia and died within 6 months.Both mviv and mvir patients with hemolysis did not have pvl but had turbulent flow from left ventricular outflow tract narrowing and their hemolysis was self-limited.Post deployment of a sapien 3 valve in an existing mitral surgical valve (viv), hemolysis was observed.The patient received a blood transfusion.No further information regarding the patient status is available.
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Manufacturer Narrative
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Per the instructions for use (ifu), hemolysis is a known potential adverse event associated with the thv procedure and the use of the edwards thv devices.Hemolysis is the destruction of red blood cells.There are multiple extrinsic and intrinsic factors including use of extracorporeal circulation, transfusion, infection, tumors, autoimmune disorders, medication side effects, a metabolic abnormality, and red blood cell membrane instability.Normal red blood cells (erythrocytes) have a lifespan of about 120 days.After the lifespan is over the red blood cells break down and are removed from the circulation by the spleen.In some medical conditions, or as a result of taking certain medications, this breakdown of red blood cells is increased.Red cells may break down due to mechanical damage, such as from artificial heart valves or heart-lung bypass; or they may be destroyed due to defects in the cells themselves.Medications that have been associated with hemolysis include acetaminophen, penicillin, and other pain medications.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest in addition to the procedure, unknown patient factors may have caused or contributed to this event.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 this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.Reference for article: el-sabawi b, guerrero me, eleid mf, nkomo vt, pislaru sv, rihal cs.Hemolysis after transcatheter mitral valve replacement in degenerated bioprostheses, annuloplasty rings, and mitral annular calcification: incidence, patient characteristics, and clinical outcomes.Catheter cardiovasc interv.2021;98:776-785.Https://doi.Org/10.1002/ccd.29779.This is one of ten manufacturer reports being submitted for this case.
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Manufacturer Narrative
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Additional information: section h10: narrative text.This is one of ten manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-06056, manufacturer report no: 2015691-2022-06057, manufacturer report no: 2015691-2022-06058, manufacturer report no: 2015691-2022-06059, manufacturer report no: 2015691-2022-06060, manufacturer report no: 2015691-2022-06061, manufacturer report no: 2015691-2022-06062, manufacturer report no: 2015691-2022-06063, manufacturer report no: 2015691-2022-06065, manufacturer report no: 2015691-2022-06088.
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