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

Model Number 9750TFX20A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Hemolysis (1886)

Event Date 09/13/2022

Event Type  Injury  

Event Description

Per the territory manager (tm), approximately 1 year and 27 days post-implant of a 20mm sapien 3 ultra valve, the patient underwent a valve in valve (viv) tavr procedure using a 20mm sapien 3 ultra valve via transfemoral approach, due to paravalvular leak (pvl).The patient had presented with mild-to-moderate pvl and hemolysis around the s3u with an additional 1cc added at the time of implant.The perceived root cause was possibly the high placement of the valve.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Correction to h6; device code, type of investigation, investigation findings, investigation conclusion.The 20mm sapien 3 ultra valve was not returned for evaluation.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.Imagery was received that showed a 3d area of the native annulus which was 355 cm2, indicative of full foreshortening upon deployment of the 20mm s3u, initial thv position prior to deployment was non-coaxial in reference to the aortic root and too high in reference to the center marker, implanted thv appeared to be 100:0 aortic/ventricular in reference to the basal plane, and the outflow side of the valve appeared to be overlapping with the height of coronary arteries.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u and procedural training manual.Based on this review, 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.The complaint for malpositioned valve was confirmed based on provided imagery.The complaint for paravalvular leak (pvl) was unable to be confirmed due to the unavailability of applicable imagery.A review of dhr, lot history, and complaint history did not provide any indication that a manufacturing nonconformance would have contributed to the reported event.In addition, a review of ifu/training materials revealed no deficiencies.As reported, "approximately 1 year and 27 days post-implant of a 20mm sapien 3 ultra valve, the patient underwent a valve in valve (viv) tavr procedure using a 20mm sapien 3 ultra valve via transfemoral approach, due to paravalvular leak (pvl).The patient presented with mild-to-moderate pvl and hemolysis around the s3u with an additional 1cc added at the time of implant.The perceived root cause was possibly the high placement of the valve (90 aortic :10 ventricular)." in this case, the imagery review confirmed the presence of a large annulus based on the thv sizing recommendations for a 20mm s3u.Additionally, the initial thv position was confirmed to be too high immediately prior to deployment.A combination of these factors likely accounts for the thv landing too aortic due to thv foreshortening and high initial placement, respectively.Available information suggests that procedural factors (improper valve positioning, undersized thv, malpositioned valve) and the likelihood that the pvl skirt was unable to properly seal against the annulus resulting in pvl may have contributed to the complaint event.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards lifesciences; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15546701
• MDR Text Key: 301235893
• Report Number: 2015691-2022-08277
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201314
• UDI-Public: (01)00690103201314(17)230304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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: 03/04/2023
• Device Model Number: 9750TFX20A
• Device Catalogue Number: 9750TFX20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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
• Patient Age: 84 YR
• Patient Sex: Female