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

Model Number 9600TFX23

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The valve was not returned to edwards lifesciences for evaluation.Information regarding the disposition of the valve was not provided.Dper the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement 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 valve annulus, uneven distribution of calcium on the valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.Some pvl is not uncommon post deployment. many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.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.  per report, the paravalvular leak resulted from the increasing leaflet restriction with overexpansion of the balloon-expandable thv and a central coaptation defect.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.Bibliography: m.C.Wyler von ballmoos, c.M.Barker, p.R.Kothapalli, et al., surgical bailout for left ventricular outflow tract obstruction following a complicated mitral valve., cardiovascular revascularization medicine, https://doi.Org/10.1016/j.Carrev.2019.07.02.7.

Event Description

As reported through journal article titled, "surgical bailout for left ventricular outflow tract obstruction following a complicated mitral valve-in-valve procedure", post valve in valve (23mm sapien 3 in 25mm surgical valve) tmvr, tee showed a small residual pvl jet.A 25mm non-compliant balloon was used to dilate the valve (approx.11.5% oversize of the inner diameter).Tee post dilatation showed improvement in the pvl and severe mitral regurgitation, consistent with disruption of the thv leaflets.Given the previous dilation with a 25 mm non-compliant balloon, a 26 mm sapien 3 thv was implanted as a thv-in-thv, at the same depth as the previous thv.The tee following the placement of the second thv now showed a significant gradient across the neo-lvot with a jet velocity n 3 m/s.Despite this, the patient was doing well and was managed medically at first.Given the etiology of obstruction and associated mortality, the patient was scheduled for elective redo-mitral valve replacement.The previous surgical valve and two thvs within it were all explanted.A 27 mm non-edwards valve was implanted, and the patient recovered from the surgery without further complications.The patient was discharged home on postoperative day 7 and continues to do well during follow up.Note: this description pertains to the first thv implanted valve.

Manufacturer Narrative

Dates are unknown.This is one of two reports being submitted for this case.  please reference manufacturer report no.  2015691-2019-03692.

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; one edwards way; irvine CA 92614
• MDR Report Key: 9157232
• MDR Text Key: 163131628
• Report Number: 2015691-2019-03680
• 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,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX23
• 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: 64 YR