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

Model Number 9300TFX26A

Device Problems Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The investigation is ongoing.

Event Description

Approximately 2 years and 9 months post implant of a 26mm sapien xt valve within a pre-existing 27mm perimount surgical valve in the pulmonic position, thickening of the valve leaflets were observed on echo.The valves were explanted.

Manufacturer Narrative

Product problem was also selected.The explanted valve was returned to edwards lifesciences for evaluation.During visual analysis host/pannus like tissue growth was observed on all valve leaflets.The frame has slightly cone shaped with the outflow smaller than the inflow, and the frame was damaged, but was considered to be likely due to explantation.No functional or dimensional testing was able to be performed due to device returned condition (frame deformation and leaflet thickening).The complaint is confirmed based on visual inspection.Per the ifu, valve leaflet thickening is a potential adverse event associated with bioprosthetic heart valves and the transcatheter heart valve replacement procedure.Over time, it is possible that leaflets may be affected by the development of calcification, or the formation of pannus/host tissue.In this case, the host tissue can be seen on both the thv and the surgical valve; likely impacting valve functionality.Host/pannus tissue growth is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue in-growth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.Although a definitive root cause could not be determined, available information suggests that patient factors (host tissue growth) may have contributed to the event.The following were reviewed for instructions/guidance for preparation and use of the devices: precautions: safety, effectiveness, and durability of the thv have not been established for implantation within a previously placed surgical or transcatheter pulmonic valve.Long-term durability has not been established for the thv.Regular medical follow-up is advised to evaluate thv performance.Potential adverse events: additional potential risks associated with the use of the thv, delivery system, and/or accessories include structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent post, leaflet retraction, suture line disruption of components of a prosthetic valve, chordal rupture, thickening, stenosis, or other).No ifu/training deficiencies were identified.During manufacturing, the valve and components are inspected several times throughout the manufacturing process.Prior to final packaging, 100% visual inspection is performed to ensure no damage was done to the valve from handling.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformances contributed to the reported events.Dhr review did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review did not reveal any other complaints related to ¿leaflet ¿thickened¿.A review of complaint history for the sapien xt (all sizes) from october 2018 to september 2019 revealed no other returned complaints for ¿leaflet ¿ thickened¿.A review of complaint history reveals that the complaint occurrence rate did not exceed the september 2019 control limit for the ¿leaflet thickening¿ trend category.The complaints for ¿leaflet ¿ thickened¿ was confirmed.Although a definitive root cause could not be determined, available information suggests that patient factors (host tissue growth) may have contributed to the event.A review of the dhr, lot history and complaint history revealed no indication that a manufacturing non-conformance contributed to the complaint.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Since no labeling or ifu/training inadequacies were identified and review of the complaint history revealed that the complaint occurrence rate did not exceed the september 2019 control limit for the applicable trend category, neither a pra nor corrective or preventative action was required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9107576
• MDR Text Key: 162810589
• Report Number: 2015691-2019-03546
• Device Sequence Number: 1
• Product Code: NPV
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2017
• Device Model Number: 9300TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR