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

Model Number 9600TFX29

Device Problem Perivalvular Leak (1457)

Patient Problems Hemolysis (1886); Mitral Regurgitation (1964); Occlusion (1984); Regurgitation (2259); Extubate (2402)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

The edwards sapien 3 transcatheter heart valve and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve, who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The use of a sapien 3 valve in a native mitral position is not indicated per the labeling; therefore, the device instructions for use and procedural training manual do not provide direction for the use of the device in this application.Paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.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.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv in on label procedures.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.There is no specific instruction for placement in a native mitral valve.Per the ifu, hemolysis is a potential risk associated with the use of the thv, delivery system, and/or accessories.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.In this case, there was no allegation or indication a device malfunction contributed to the adverse events.Although the exact cause could not be determined, procedural factors (deployment position of the valve), in addition to patient factors (severe mac) may have contributed to the mild pvl post valve deployment.The pvl, through the ¿uncovered stent frame¿ and patient factors not provided, may have contributed to the reported hemolysis and subsequent renal injury.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.Reference for the article: adams hsl, rajani r, hildick-smith d, redwood s.¿between a rock and the mitral valve space¿: transcatheter mitral valve-in-valve implantation for paravalvular leak and refractory hemolysis complicated by circumflex coronary occlusion¿.Catheter cardiovasc interv.2019;1¿4.Https://doi.Org/10.1002/ccd.28573.

Event Description

As reported by our affiliate in the united kingdom and through an article, ¿between a rock and the mitral valve space: transcatheter mitral valve-in-valve implantation for paravalvular leak and refractory hemolysis complicated by circumflex coronary occlusion¿ a 29mm sapien 3 valve was implanted in the native mitral valve via the transseptal approach.Post valve deployment, mild paravalvular leak (pvl) and a mean gradient of 2 mmhg were observed.The patient was extubated and transferred to the cardiac care unit.On postoperative day (pod) 2, transesophageal echocardiography (toe) revealed mild pvl with regurgitation passing through the uncovered part of the sapien 3 valve frame on the lv aspect of the implanted valve, , leading to mechanical hemolysis and subsequent anuric renal failure.Attempts to treat the pvl with an occlusion plug device were unsuccessful and led to left circumflex coronary occlusion secondary to mechanical compression of the vessel in the posterior mitral valve annulus.The plug was removed.During a valve-in-valve procedure, a second 29mm sapien 3 valve was carefully positioned deeper within the lv to treat the pvl.Immediate angioplasty resolved the left circumflex occlusion.The patient recovered with no further hemolysis but remained anuric until discharge and is requiring permanent hemodialysis as an outpatient at 6-week follow-up.The native mitral valve area measured 0.9 cm2 by planimetry with a pressure half-time mean gradient of 11 mmhg, an estimated right ventricular systolic pressure of 45 mmhg, and a lv ejection fraction of 50%.

Manufacturer Narrative

Corrected information: date of event.Additional information received indicated the valve in valve procedure was performed on pod27.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9364956
• MDR Text Key: 168442178
• Report Number: 2015691-2019-04375
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 07/23/2020
• Supplement Dates FDA Received: 12/11/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 80 YR