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

Model Number 9600TFX29A

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

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

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6) registry.This is two of two reports being submitted for this case.  please reference manufacturer report no.2015691-2019-02953.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter mitral valve replacement (tmvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to mitral malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, minimally or bulky/severely calcification in landing zone, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Deployment of the sapien 3 valve too atrial has the potential to contribute to suboptimal coaptation of the valve leaflets and cause transvalvular regurgitation; it can also lead to embolization of the prosthesis into the left atrium.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the valve malposition post deployment cannot be confirmed.It is possible that procedural factors (transseptal approach) and patient factors (challenging anatomy) may have contributed to the second s3 valve landing in a too atrial position.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.

Event Description

As reported by a field clinical specialist, during a transseptal mitral valve-in-valve procedure, a 29mm sapien 3 valve was implanted in a 29mm sapien 3 valve that had migrated and was sitting 80% in the left atrium.Post deployment images showed that the second s3 valve landed in the same spot as the first valve (80% in the left atrium).  in order to hold the other two valves, a third 29mm sapien 3 valve was implanted successfully.The patient is currently stable.The physicians think that the normal pulsating pressure of the heart combined with the challenging landing zone contributed to the migration.

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: 8879762
• MDR Text Key: 154163366
• Report Number: 2015691-2019-02954
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 78 YR