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

Model Number 9600TFX29A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported through the implant patient registry (ipr) department, during the tvr procedure in the mitral position, the valve was explanted.

Manufacturer Narrative

The explanted valve was not returned to edwards for evaluation.  the location of the valve is unknown at this time.  information pertaining to the reason for explant was not provided.  however, additional information provided by the hospital medical records indicated the patient underwent mvr with a transcatheter tissue valve via sternotomy and remained with open sternum until pod1 after developing significant bleeding that had to be packed.  the patient failed extubation twice and was trached on pod8.  the patient tolerated trach collar during the day and ventilator at night.  the patient was discharged to a long term acute care hospital.     in this case, there was no allegation or indication a device malfunction contributed to this adverse event.  with such limited information, the reason for the valve explant cannot be confirmed.  it is possible that the patient factors and co-morbidities may have contributed to the valve explant.  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: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7584996
• MDR Text Key: 110573218
• Report Number: 2015691-2018-02227
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/22/2020
• 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: 66 YR