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

Model Number 9600TFX26A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  Injury  

Event Description

As reported by our field clinical specialist, after placement of the 26mm sapien 3 valve in the pulmonic position, an angiogram demonstrated significant regurgitation.Ice confirmed a non-function leaflet.A 29mm thv was then placed inside of the 26mm thv and performed as excepted.Ice confirmed a fully functioning thv.There was no known or suspected cause of the non-functioning leaflet.There was no surgical leaflet overhang.The last know patient status was completely stable.

Manufacturer Narrative

Investigation is ongoing.Valve remains implanted.

Manufacturer Narrative

Correction to d2, and g4, to reflect pulmonic position.A no product returned engineering evaluation was performed.As no product was returned, visual inspection, functional testing and dimensional testing could not be performed.No imagery was returned for review.Review of complaint activities/attachments revealed the following information relevant to the complaints event: this was not patient prothesis mismatch.There was no know or suspected cause of a non-functioning leaflet.The significant regurgitation was central.The initial 26mmthv had 2 extra ml's of volume.The balloon did not burst.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the relevant work order was performed and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.Commander delivery system with s3 thv, pulmonic, us ifu, preparation training manual, pulmonic position, and procedural training manual, pulmonic position were reviewed.No ifu/training deficiencies were identified.The ifu indicates ''to maintain proper valve leaflet coaptation, do not overinflate the deployment balloon.'' as the complaint was unable to be confirmed, a complaint history review is not required.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.Since no product non-conformances were identified, a product risk assessment (pra) escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.The complaints were unable to be confirmed.Due to the unavailability of the device and relevant imagery, engineering was unable to perform further evaluation.A review of the dhr and lot history revealed no indication that a manufacturing non-conformance contributed to the complaint.Review of ifu/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.There are multiple patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning leaflet and central regurgitation including malposition of the valve, impingement of a leaflet due to the calcification, improper expansion, post-dilation of the implanted valve.All these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.As reported, ''the initial 26mmthv had 2 extra ml's of volume''.Per ifu, ''to maintain proper valve leaflet coaptation, do not overinflate the deployment balloon''.It is possible that the leaflet was damaged during valve deployment due to over inflation and that prevented the leaflets from proper movement leading to the reported leaflet motion restricted and central regurgitation.As such, available information suggests that procedural factors (thv over-expanded) may have contributed to the complaint events.However, a definitive root cause was unable to be determined at this time.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.

• 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 92532
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12910170
• MDR Text Key: 282392196
• Report Number: 2015691-2021-06612
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)230520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: 9600TFX26A
• Device Catalogue Number: 9600TFX26A
• Device Lot Number: 8558224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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