MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 VALVE FOR TRANSCATHETER PULMONARY VALVE REPLACEMENT; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/09/2021

Event Type  Injury  

Event Description

My (b)(6) son underwent a heart cath for transcatheter pulmonic heart valve replacement with the edwards sapien 3 valve for transcatheter pulmonary valve replacement.During deployment of the valve, the balloon ruptured and was unable to be pulled back into the sheath.This required an emergency femoral cut-down by cardiothoracic surgery with a venous and arterial repair.While attempting to retrieve the balloon, my son sustained a large volume blood loss and required several units of blood.Because the valve was not fully deployed at the time of balloon rupture, the interventional cardiologist used a second deployment system to fully seat the valve.Other results of the balloon failure included prolonged operating room time, prolonged intubation, pulmonary hemorrhage, and prolonged cvicu stay.He was suppose to stay overnight and be discharged the next day, the balloon rupture extended his stay by more than 4 days and resulted in significant increase in cost.He was discharged home with a wound vac and required an increase in follow up to attend to the wound required to retrieve the balloon.Because of the blood loss and prolonged intubation, his overall recovery time increased from a few days to more than a month.In researching this device, i noted that there was a safety notice on another one of this mfr's valves r/t balloon failure.Edwards released special instructions with the sapien 3 ultra transcatheter aortic valve replacement (tavr) after reports of balloon failure with it's delivery system.There was also a recall on the edwards intraclude intra-aortic occlusion device after three deaths were linked to ruptured cardiovascular balloons used in those systems.I would like to propose that the fda investigate the deployment system for the "edwards sapien 3 valve for transcatheter pulmonary valve replacement" to ensure that there is not a pattern of balloon failure causing harm to patients.I would be happy to sign consent for you to review any and all of my son's medical records involving this product.Of note, as my son is developmentally delayed, i am his power of attorney and have the authority to communicate and sign for release on his behalf.(b)(6).Fda safety report id # (b)(4).

• Brand Name: EDWARDS SAPIEN 3 VALVE FOR TRANSCATHETER PULMONARY VALVE REPLACEMENT
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 12487637
• MDR Text Key: 272454329
• Report Number: MW5104046
• Device Sequence Number: 1
• Product Code: NPV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 20 YR
• Patient Weight: 52