MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Obstruction/Occlusion (2422)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Bibliography: john-peder escobar kvitting md, p.(2018).Surgical management of outflow tract obstruction after transapical mitral valve implantation.Journal of cardiac surgery, 1-3.The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to 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 high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).Obstruction of the left ventricular outflow tract can be caused by patient factors (anterior mitral leaflet protruding into the lvot, septal hypertrophy, hypovolemia, increased cathecolamine drive, less than 110-degree angle between the mitral and aortic annular planes) or procedural factors (positioning of the valve frame within the annulus).Depending on the degree of obstruction, cardiac output and hemodynamic stability may be affected.Inaccurate deployment is generally a result of use error or a combination or patient and procedural factors.In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require explanation of the thv with surgical correction.It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.The device was not returned to edwards lifesciences for evaluation.However, there was no allegation or indication a device malfunction contributed to this adverse event.As reported, a sapien 3 valve was placed within a mitral ring in the intended position.Post deployment the lvot gradient increased to 112 mmhg and significant sam of the mitral valve with lvot obstruction from the displaced aml was noted.Investigation results suggest as per article, that following the tmvi procedure, the thv stent frame displaced the aml into a fixed position in the lvot, preventing it from moving towards the mitral ring during systole resulting in lvot obstruction and high gradients.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 at this time.

Event Description

As reported through our (b)(4) affiliate, a (b)(6) male underwent a mitral valve repair in 2015 for mitral regurgitation using an annuloplasty ring.Four months following surgery an echo showed severe mitral regurgitation and a 29mm sapien 3 valve was implanted into the mitral annuloplasty ring by apical access as published in the journal article ¿surgical management of outflow tract obstruction after transapical mitral valve implantation¿.The valve was implanted in a 55:45 atrium/ventricle position.An echo (tee) directly after implantation showed significant sam (systolic anterior motion) of the of the anterior mitral valve leaflet (aml) with lvot (left ventricular outflow tract) obstruction with a gradient of 60 mmhg at a heart rate of 38 bpm and radial pressure of 66 mmhg.With the same heart rate and a radial systolic pressure of 90 mmhg the lvot gradient increased to 75 mmhg.The patient was not significantly improved by bradycardia, volume replacement, or discontinuation of inotropic drugs.After a multidisciplinary discussion in the catheterization laboratory the patient was transferred to the operating room for surgical treatment of the lvot obstruction.The chordae of the aml were cut at the level of the papillary muscles and the aml was cut at the base and resected.The patient was weaned uneventfully from cardiopulmonary bypass.Tee confirmed a patent aortic valve with trivial paravalvular leakage in the mitral valve prosthesis with a lvot gradient of 20 mmhg at a heart rate of 75 bpm.The patient was discharged on the fifth postoperative day to his local hospital.On the latest follow-up the patient was in nyha class i.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7773899
• MDR Text Key: 116858541
• Report Number: 2015691-2018-03320
• 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
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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
• 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: 74 YR