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

Model Number 9300TFX26

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4) investigation is ongoing.

Event Description

As found through implant patient registry (ipr), 23 months post implant of the 26mm sapien xt valve in a surgical , the valves were explanted and replaced with an edwards intuity elite.The reason for explant is unknown at this time.Per medical records of initial implant, the 26 mm edward sapien xt valve was positioned under rapid pacing.The patient tolerated the procedure well and there was no perivalvular leak.The patient was transferred to the cardiac intensive care unit in critical but stable condition.Echo performed on post operative day one showed the prosthetic aortic valve was well-seated and appeared to open well.The max pressure gradient was 3m/sec, mean pressure gradient 19.3mmhg and the ava was 1.0 cm2.The patient was discharged to home on postoperative day two.

Manufacturer Narrative

Update to g4, h2, h6 and h10.Multiple attempts have been made to obtain additional information with no response.At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.To date, the patient medical records and procedure op notes requested have not been received for review.  a supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.  in this case, the valve is not available for evaluation; however, there was no indication or allegation that a product deficiency contributed to the event.  the reason for explanting the valve approximately 23 months post tavr is not available at this time.  there is insufficient information to determine if the event was related to a device malfunction.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9709076
• MDR Text Key: 189458565
• Report Number: 2015691-2020-10503
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2020

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: 05/22/2017
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/06/2020; 07/23/2020
• Supplement Dates FDA Received: 03/06/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR