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

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Off-Label Use (1494); Insufficient Information (3190)

Patient Problems Mitral Regurgitation (1964); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by the edwards implant patient registry, during an off-label mitral valve replacement procedure, a 29mm sapien 3 valve was implanted in the native mitral valve.The valve was explanted 46 days post deployment and an edwards surgical valve was implanted.No further information is available at this time.

Event Description

As reported by the edwards implant patient registry, during an off-label mitral valve replacement procedure, a 29mm sapien 3 valve was implanted in the native mitral valve.Medical record review revealed during a transfemoral transcatheter mitral valve replacement (tmvr) procedure, the sapien 3 valve was positioned and deployed in a final 50:50 position across the mitral annulus.Post valve deployment, moderate paravalvular leak (pvl) was observed.The valve was post dilated with no improvement of the pvl.Due to concern about the possible migration of the valve atrially, the procedure was completed.No increased gradient across the lvot was noted.The septostomy was closed and the patient was transferred to recovery in stable condition.Post procedure, complete heart block occurred.A permanent pacemaker (ppm) was implanted on postoperative day (pod) 4.Tte performed on pod6 indicated ¿significant¿ residual pvl.On pod7, following discussion with the patient concerning surgical intervention in ¿a few weeks¿, the patient was discharged.Echo performed on pod27 showed a mean gradient of 12 mmhg, mild pvl and mild central mitral regurgitation.The patient reported feeling ¿excellent¿, but complained of fatigue since discharge.The patient returned for surgical mitral valve replacement on pod46.The sapien 3 valve was explanted and a magna bioprosthetic mitral valve was implanted.The patient tolerated the procedure well.She was discharged to home 9 days after the surgical mitral valve procedure.

Manufacturer Narrative

Corrected information: date of event.Event date corrected to reflect the date of event.Additional information: description of event; other relevant history; patient code; evaluation codes; section narrative text.The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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 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 edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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).Paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement 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.Conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tvr procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, atrioventricular conduction disturbances after tvr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.It is also documented that pre-existing heart block is common in patients undergoing tvr or surgical mvr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate patient factors (severe mitral annular valve calcification) likely contributed to the moderate pvl and subsequent sapien 3 valve explant and implant of a surgical mitral valve.Investigation results suggest/indicate in addition to procedural factors (pressure from the implanted valve on cardiac structures), patient factors (severe mitral annular valve calcification) likely contributed to the complete heart block post procedure and subsequent ppm implant.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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8807754
• MDR Text Key: 151604512
• Report Number: 2015691-2019-02668
• Device Sequence Number: 1
• Product Code: NPT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: 9600TFX29A
• 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: 70 YR