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

Model Number 9600TFX26

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Sepsis (2067); Injury (2348); No Code Available (3191)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve embolization is a known potential complication 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 valve embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, minimally or bulky/severely calcified leaflets, rapid deployment, loss of pacing capture, release of stored tension during deployment, and movement of the delivery system by the operator.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.Investigation results suggest/indicate procedural factors (underestimated mitral chordal apparatus, resistance) may have contributed to the valve position, valve embolization into the atrium and subsequent valve explant.There was no allegation that the patient death due to sepsis was related to the sapien 3 valve.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 our affiliate in (b)(6), during a transfemoral mitral valve in ring procedure, a 26mm sapien 3 valve was deployed in a pre-existing mitral surgical ring.The valve was deployed in a 50:50 position in the existing mitral ring.Post valve deployment, the valve embolized into the atrium.The patient was transferred to the operating room.The sapien 3 valve was explanted from the left atrium.A surgical mitral valve replacement was performed.A non-edwards surgical valve was implanted.Post procedure, sepsis occurred.The patient expired on postoperative day (pod) 13.It was perceived that the valve embolization was caused by an underestimated mitral chordae apparatus which caused a ¿tenacious¿ resistance.

Manufacturer Narrative

Additional information indicated the surgical valve was functioning properly.The post procedure sepsis was caused by staphylococcus epidermidis, without endocarditis.The patient expired on postoperative day (pod) 13.The cause of death was reported to be sepsis.There was no indication or allegation that the edwards devices caused or contributed to the patient death.

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: 10105320
• MDR Text Key: 193110089
• Report Number: 2015691-2020-12019
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 9600TFX26
• 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: 71 YR