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 Problems Mitral Regurgitation (1964); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/20/2020

Event Type  Death  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of mitral valve reintervention for the sapien 3 in the mitral position.The ¿time to event¿ (tte, in days) for this event was 71.   the device identification (di) numbers for edwards sapien 3 transcatheter heart valve is (b)(4).  mitral valve re-intervention in the follow-up period (in the absence of prosthetic cardiac valve thrombosis) will typically result from on-going or worsening regurgitation, valve degeneration related to  the formation of calcification or pannus, or valve migration.These events are identified in the product instructions for use (ifu) as potential risks associated with the use of the thv.  regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanism of calcification of biomaterials is not completely understood, but is probably related to an inability of the non-viable cells to maintain their normally low intracellular concentration of calcium.Another potential condition that may lead to re-intervention is patient prosthesis mis-match and/or under-expanded valves due to thv restriction from the existing valve frame.Incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.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

Thv/tvt registry alternative summary reporting (asr) adverse event submission for august 2020 data extract for mitral deaths for the sapien 3.August 2020 data extract includes data provided by acc for q1 2020 (january 1 ¿ march 31, 2020).This report summarizes 1 death event of mitral regurgitation for the sapien 3 for august 2020.

Event Description

This report summarize  1  death event of mitral valve regurgitation for the sapien 3 for (b)(6) 2020.

Manufacturer Narrative

Supplemental report to add noe statement in b5 section, and provide d5, and h6 information.

• 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: 10870193
• MDR Text Key: 217183716
• Report Number: 2015691-2020-14499
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR