MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER, 26MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26A

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Hemolysis (1886); Mitral Regurgitation (1964); Renal Failure (2041); Hemolytic Anemia (2279)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown; however, the article was first received for publication on december 27, 2019.Therefore, the date was used as the occurrence date.Article reference: el-sabawi b, guerrero me, eleid mf, rihal cs.Acute fulminant hemolysis after transcatheter mitral valve replacement for mitral annular calcification.Catheterization and cardiovascular interventions.2020 may 6.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.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 they die they 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.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.The patient screening manual instructs the operator on proper aortic valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.In this case, patient factors (mitral stenosis with mac) was a likely contributing factor for the pvl and subsequent hemolysis.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Event Description

Per the literature article, ¿acute fulminant hemolysis after transcatheter mitral valve replacement for mitral annular calcification¿, tmvr with a 26 mm sapien 3 valve was performed on a patient with mitral stenosis with mitral annular calcification (mac).After implant with 5cc of additional inflation volume, the valve was well seated with mild paravalvular leak (pvl).Post procedure, the patient developed acute profound hemolysis which manifested with hemoglobinuria, transfusion-dependent anemia, and acute renal failure requiring renal replacement therapy.10 days post procedure, the patient was taken back to the cath lab for mitral pvl closure.After failed transcatheter pvl closure, the valve was post-dilated with an additional 8cc of inflation volume with resulting improvement in the pvl.The hemolytic anemia resolved and renal function recovered without the need for continued hemodialysis 2 months later and stabilization of glomerular filtration rate at 6 months.At the most recent follow-up 10 months after tmvr, the patient was doing well with nyha class ii dyspnea, was active without any limitation in activities of daily living, and had no heart failure readmissions after tmvr.Per the authors, pvl is common following tmvr for severe mac and can lead to heart failure symptoms and/or intravascular hemolysis.The mitral annulus area measured 600 mm2.The lvot area was 342 mm2.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER, 26MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10124146
• MDR Text Key: 195635220
• Report Number: 2015691-2020-12085
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR