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

Model Number 9300TFX26

Device Problems Leak/Splash (1354); Material Perforation (2205); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Regurgitation (2259)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Bibliography: lipinski, j., et al."transcatheter valve implantation for failed surgical aortic and mitral bioprostheses: a single-center experience." the journal of invasive cardiology (2020).

Event Description

As reported through a journal article titled, "transcatheter valve implantation for failed surgical aortic and mitral bioprostheses: a single-center experience", three years post deployment of a 26mm sapien xt valve, the patient underwent a valve in valve (29mm evolut valve in 26mm sapien xt valve) tavr procedure to address the regurgitation caused by, "failure due to a perforated leaflet".

Manufacturer Narrative

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

Manufacturer Narrative

Section h6 and h10: the valve was not returned to edwards lifesciences for evaluation, as it remains implanted in the patient.Additionally, no photos/imagery were provided to edwards lifesciences for review.During manufacturing of the sapien xt valves, the leaflet and frame components were inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.As no serial number was provided, a device history record (dhr) review or lot history review was unable to be conducted.The complaint was unable to be confirmed and the complaint occurrence rate did not exceed the april 2020 control limit for the trend category; therefore, a complaint history review was not required.The novaflex+ delivery system, us instructions for use (ifu), and the device prepping manual were reviewed for instructions relating to the complaint event.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.Due to the device unavailability and lack of procedural imagery, the complaint was unable to be confirmed.A review of manufacturing mitigations supports that the valve has proper inspections in place to detect issues related to the complaint events.A review of ifu/training revealed no deficiencies.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Leaflet damaged (perforated leaflet) of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and leaflet damage.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.In this case, there was insufficient information to determine the definitive root cause.The complaint history revealed that the complaint occurrence rate did not exceed the april 2020 control limit for the applicable trend category, neither a pra nor corrective or preventative action was required at this time.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9940135
• MDR Text Key: 190030289
• Report Number: 2015691-2020-11375
• 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: 03/17/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 07/23/2020
• Supplement Dates FDA Received: 06/02/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention