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

Model Number 9600TFX29A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Multiple attempts have been made to obtain additional information with no response.At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.To date, the patient medical records and procedure op notes requested have not been received for review.  a supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.In this case, the valve is not available for evaluation; however, there was no indication or allegation that a product deficiency contributed to the event.  the reason for explanting the valve approximately 2 months post tavr is not available at this time.  there is insufficient information to determine if the event was related to a device malfunction.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 from implant patient registry (ipr), approximately 2 months post transcatheter valve replacement (tvr) with a 29mm sapien 3 valve in a previously implanted mitral ring, the valve was explanted and a surgical valve was replaced.The reason for the explant is unknown at this time.

Manufacturer Narrative

Thv/tvt registry.Per medical records received, the patient underwent tmvr with placement of a 29mm s3 valve within a 32mm mitral ring to treat symptomatic mitral regurgitation.She developed a dynamic obstruction due to long native anterior mitral leaflet overhanging the s3 valve frame and associated sam.Approximately 2 months post tmvr the patient noted worsening dyspnea and fatigue, as well as increasing edema prompting rehospitalization.Echo demonstrated normal lv ejection fraction, with severe lvot obstruction with sam, moderate tricuspid regurgitation (tr) and severely increased pulmonary pressures by tr the patient was admitted for treatment of new-lvot modification resulting in lvot obstruction and severe tricuspid regurgitation velocity and right atrial pressures.The patient was admitted for lampoon procedure, which was unsuccessful with return of lvot gradient.It was decided to perform redo sternotomy for mvr and tricuspid valve repair.The patient tolerated the procedure well.Hospital course was complicated by anuric renal failure, recurrent atrial fibrillation, hematoma, non-occlusive thrombus in left internal jugular vein which was successfully removed, complete heart block with permanent pacemaker.The patient recovered sufficiently to be discharged home in stable condition 30 days post explant procedure.In this case event additional information reported that the event was due to anatomical factors (neo-lvot modification resulting in dynamic obstruction due to sam) and was not associated with an edwards device malfunction or failure and the adverse event (lvot obstruction) is listed in the labeling.The event was investigated by edwards lifesciences and found not to meet the criteria for a 3500a mdr form reportable event and a corrected report is being submitted.

• 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: 10174368
• MDR Text Key: 199085738
• Report Number: 2015691-2020-12213
• 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: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR