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

Model Number 9600TFX23A

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported through the edwards lifesciences implant patient registry, 44 days post implant of a 23mm sapien 3 valve in the mitral position, a 26mm sapien 3 valve was implanted.No further information is available at this time.

Manufacturer Narrative

This 3500a form are listed below; system updates pending.Result code: known inherent risk of procedure.Udi number: ((b)(4).The edwards sapien 3 transcatheter heart valve (thv), and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (b)(4).In this case, there is no malfunction of the sapien 3 valve, the broken suture used to secure the implanted valve maybe related to suturing technique, materials, or patient factors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Event Description

A 23mm sapien 3 valve was surgically implanted in the mitral position, because the planned mitral surgical valve would not fit/work.About 44 days post valve implant, follow-up echo indicated that one of the sutures used to implant the sapien 3 valve had broken.The patient was taken to surgery that same day.The 23mm sapien 3 valve was explanted and a 26mm sapien 3 valve was implanted via a right mini thoracotomy.Multiple sutures were used to secure the valve.Upon completion of the procedure, the patient was in stable condition.

Manufacturer Narrative

Section of this report has been updated to reflect the correct aware date for the event.The correct aware date for the event was confirmed on (b)(6) 2016 and was previously reported under follow-up 1 of this manufacturing report.

• 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: 5500964
• MDR Text Key: 40356871
• Report Number: 2015691-2016-00793
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2016
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2016; 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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: 71 YR