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

Model Number 9600TFX29A

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter mitral valve replacement.According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the landing zone wall.Stent valves are subjected to antegrade ejection forces during systole.Less-than-severe and non-uniformly distributed calcification of the native leaflets, incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.Additionally, residual overhanging leaflets can exert downwards force during diastole, causing migration of the thv towards the left ventricle.  per the sapien 3 instructions for use (ifu), lvot obstruction a potential risk associated with the use of the valve, delivery system, and/or accessories.  lvot obstruction is usually due to inaccurate deployment (too ventricular) of the valve and is generally a result of use error or a combination of patient and procedural factors.In most cases of postoperative lvot obstruction, the obstruction results from the protrusion of the anterior mitral valve leaflet into the lvot or from abnormal subvalvular positioning of the prosthesis.Additionally, lvot obstruction may occur postoperatively if there is a narrowed mitral-aortic angle, or due to a thickened interventricular septum.Other possible causes include a hyper contractile left ventricle or atrial fibrillation.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.   the edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.Deployment of the sapien 3 valve in a native mitral valve is not indicated per the labeling; therefore the device labeling (ifus and training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.  in this case, there was no allegation or indication that a device malfunction contributed to this adverse event.  the cause of the migration and the subsequent lvot obstruction cannot be confirmed, however per the medical records review, post tmvr the patient experienced an episode of cardiac arrest of unclear etiology that required cpr which resulted in the displacement of the s3 valve to the lvot causing lvot obstruction.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

As reported through implant patient registry, a 29mm sapien 3 (s3) valve was implanted in the mitral position and approximately 4 days post implant a 2nd 29mm sapien 3 valve was implanted in the same position.Additional details were not provided.Medical records review revealed that the 1st s3 valve was explanted due to migration resulting in left ventricle outflow tract (lvot) obstruction and replaced with the 2nd s3 valve.Patient with very complex past medical history including moderate to severe mitral stenosis (ms) due to heavy posterior mitral annular calcification, as s/p tavr with 23mm sapien 3 valve.The patient had symptoms of exertional shortness of breath, fatigue and lack of energy.Cardiac workup revealed moderate to severe ms with mild mitral regurgitation (mr).The patient was recommended to undergo a minimally invasive robotic assisted mitral valve replacement (mvr) and closure of the left atrial appendage.Due to heavy mitral annular calcification (mac), a sapien 3 valve was recommended via open chest approach.  during the mvr procedure the annulus was measured and a 29mm sapien 3 valve was found to be a good fit.A ptfe felt strip was sutured circumferentially inside the mitral annulus.The s3 valve was deployed slowly, making sure that 30% of the valve was located in the left atrium and another 60% post was inside the left ventricle.  post deployment the valve position was satisfactory and was anchored by the metal frame to the felt strip with sutures.The valve was competent with no visible paravalvular leakage.A left ventricle vent was inserted through the mitral valve and the case was concluded.  the patient was wean-off bypass without difficulties.  tee showed no paravalvular leak (pvl), the valve leaflets were moving properly and the gradient was between 2-3 mmhg.  the patient tolerated the procedure well and was transferred to the recovery room.Post procedure, the hospital course was complicated by an episode of bradycardia cardiac arrest of unclear etiology on post-operative (pod) 3 that required cpr with subsequent displacement of the s3 valve to the lvot, resulting in lvot obstruction, severe mitral pvl requiring hemodynamic support.The patient responded to cpr and was paced.  post cpr echocardiogram showed an increased lvot obstruction with mean gradient of 50mmhg.The patient subsequently required replacement of the displaced s3 valve with another s3 valve on pod-4.Post deployment the 2nd valve the valve functioned properly, and it was in satisfactory position with mean gradient of 3mmhg.   however, the gradient in the lvot remained to be high, which could be due to the patient¿s underlying lv myocardial hypertrophy and hyperdynamic status from inotropic support.A tte performed on the following day reported that the mitral valve leaflets appeared normal, with mean gradient of 5.67 mmhg.There was moderate pvl.A tte performed one week after 2nd mvr procedure reported that the s3 valve in the mitral valve appeared to be normal, the distal stent struts were extending to the lvot causing obstruction to the outflow.It also reported ¿small lv cavity with global systolic function hyperdynamic.Severe dynamic lvot obstructive gradient at rest.¿ eight (8) days after implant of the 2nd s3 valve, the patient underwent a redo mvr due to the significant lvot obstruction and a 27mm conventional porcine valve was placed.Initially the patient did well.After the second mvr the patient required peripheral ecmo support due to acute respiratory failure leading to cardiac arrest, with cardiogenic shock on pod-6 requiring ecmo support for several days.Other complications included right limb ischemia requiring reposition of the ecmo cannula with placement of femoral vascular grafts, thrombocytopenia, coagulopathy, acute hypoxemic respiratory failure, shock liver, acute kidney injury, lactic acidosis, acute on chronic anemia due to blood loss and leukocytosis.The patient condition continue to deteriorate and the patient passed away 4 days after the 3rd mvt procedure.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information as per review of medical records.The section narrative text (h10) of this report has been updated.Per the instructions for use (ifu), arrhythmias and conduction system defects (which may require a permanent pacemaker) are known potential adverse events associated with balloon valvuloplasty, the use of local and/or general anesthesia, aortic valve replacement and the overall tavr procedure.Slow heart rates or bradycardia have many potential causes including disturbances in automaticity and conduction, medications including general anesthesia, electrolyte imbalances, advanced age, and cardiac diseases.If this cannot be managed with medication, permanent pacemaker implantation may be necessary.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.  the cause for the bradycardia may be due to patient co-morbidities (moderate to severe mitral stenosis, cti ablation in 2018, hep c, htn, pulmonary htn, drug abuse).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.

Manufacturer Narrative

A supplemental mdr is being submitted for the reference of mfg.Report number.This report is 1 of 2 being submitted for this complaint.Reference mfg.Report no.2015691-2021-00262.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11325759
• MDR Text Key: 232326288
• Report Number: 2015691-2021-00261
• 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: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS COMMANDER DS, ESHEATH.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR