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

Model Number 9600TFX26A

Device Problem Activation Failure (3270)

Patient Problem Injury (2348)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4). investigation is ongoing.

Event Description

As reported, approximately 2 years post transcatheter valve replacement (tvr) procedure with a 26mm sapien 3 valve implanted in the mitral position within a 27mm surgical valve, the valve was under expanded.A new 26mm sapien 3 ultra was implanted successfully.  the patient is stable post procedure.

Manufacturer Narrative

Under expansion of the deployed valve could result in pvl.If the pvl is not clinically significant, the pvl may resolve over time requiring no intervention to treat.Some instances, the pvl may be significant requiring intervention (e.G.Viv, surgical intervention, vascular plug).Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In this case, there was no allegation or indication a product deficiency contributed to this adverse event.  the cause of the valve under expansion cannot be confirmed with the limited information, however, may be related to patient/procedural factors not provided.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.

• 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: 10766449
• MDR Text Key: 214148236
• Report Number: 2015691-2020-14199
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention