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

Model Number 9600TFX23J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As reported by our (b)(4) affiliate, after post-dilation with additional volume the 23mm sapien 3 valve had moderate central leak and a valve-in-valve procedure was performed.At the beginning of the procedure, the right coronary artery was protected due to low height of 7.9mm.A 23mm sapien 3 valve was deployed without problem in a 70:30 aortic/ventricular position.Post-deployment, echo showed mild paravalvular leak (pvl) and post-dilation was performed with an additional 1ml contrast solution added to the nominal volume.After post-dilation, moderate central leak was observed from the right coronary cusp ¿ left coronary cusp.The echo showed a motion abnormality in the leaflets.A new 23mm s3 valve was implanted in the first valve.The procedure was completed after confirming the final pvl was trivial.A guiding catheter had been inserted through the s3 valve's stent for coronary angiography post valve deployment.At that time, the physician felt some resistance.At the end of the procedure, the physician speculated that the valve leaflet might have been damaged while manipulating the guiding catheter post deployment of the first valve.However, it was unclear whether the resistance was a cause of the event.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7312277
• MDR Text Key: 101464819
• Report Number: 2015691-2018-00758
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR