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

Model Number 9600TFX29A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Mitral Regurgitation (1964)

Event Date 10/10/2019

Event Type  Death  

Manufacturer Narrative

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.The device identification (di) number is (b)(4).

Event Description

Per the information received from the thv/tvt registry for (b)(6) 2020 data extract for mitral deaths for the sapien 3 transcatheter heart valve, a (mitral valve reintervention) occurred, and the patient expired. no additional information is available for this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10405797
• MDR Text Key: 202856590
• Report Number: 2015691-2020-13123
• 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
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR