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

Model Number 9600TFX29

Device Problem Incomplete Coaptation (2507)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6), during a transcatheter valve with a 29mm sapien 3 in the pulmonary position, post implant, abnormal leaflet coaptation and severe pulmonary regurgitation were noted. a valve in valve was performed with a second 29mm sapein 3 valve.   during 2nd valve implant, the commander balloon burst.The delivery system was removed, and the valve was post dilated resulting in residual moderate pulmonary regurgitation (intra thv valve).   the patient is in stable condition post procedure.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-15074.The valve was not returned to edwards lifesciences for evaluation.  a review of imagery provided showed post tpvr, calcification spot on patient¿s native pulmonic valve was observed.During manufacturing, all sapien 3 valves are 100% visually inspected by both manufacturing and quality for any defects.Prior to final packaging, 100% visual inspection is performed at preliminary packaging.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the complaint event.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was performed and revealed no other similar complaints for leaflet inadequate coaptation in patient.  a review of the risk management documentation was performed, and 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.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.The complaint for leaflet inadequate coaptation in patient was unable to be confirmed due to the unavailability of the valve and / or relevant images.However, a review of the dhr, and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that proper inspections are in place to detect issues relating to the complaint.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 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.As reported, ¿valve was implanted with nominal volume at pv and post dilatation with 2 cc overfilling.After implanted the valve without issues, it was found abnormal leaflets coaptation and severe pr by tte¿.In this case, the thv was post-dilated with extra 2ml of volume.Procedural training manual, lists ¿central ar¿ as risks associated with post dilation.It is possible that the post-dilation resulted in overexpansion of the valve, thus impacting the proper functionality of the leaflets.Additionally, it was reported that calcium chunk was seen at pulmonic valve.It could be possible that the calcium was protruding through a valve strut window and in contact with leaflets, impinging or disrupting the leaflet functionality.As such, available information suggests that patient factors (calcified native valve) and/or procedural factors (overexpansion of thv) may have contributed to the complaint event.Since no manufacturing non-conformances or ifu deficiencies were identified, corrective action and product risk assessment are not required.

• Brand Name: EDWARDS SAPIEN 3 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: 11037668
• MDR Text Key: 222342094
• Report Number: 2015691-2020-15073
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR