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

Model Number 9600TFX

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/16/2019

Event Type  Injury  

Event Description

During a transcatheter pulmonary valve replacement, the balloon of edwards sapien 3 device failed on deployment leaving the valve partially deployed.Fda safety report id# (b)(4).

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 8582318
• MDR Text Key: 144237576
• Report Number: MW5086375
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 9600TFX
• Device Catalogue Number: 9600TFX23A
• Device Lot Number: (17)200730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 75