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

Model Number 9750TFX23A

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Valve not returned for evaluation.

Event Description

As reported, approximately 2 years, 5 months post successful tavr implant the 23mm sapien 3 ultra valve was explanted and replaced with a surgical heart valve.

Event Description

Medical records were received for review.Tee performed 2 years, 3 months post tavr indicated the 23mm s3u valve was well seated in the lvot.The valve was structurally normal with normal leaflet motion.There was severe patient prosthetic mismatch.The aortic valve peak velocity was 4.0 m/s.The aortic valve mean gradient was 37.4 mmhg, valve area by planimetry was 1.12 cm2 and indexed aortic valve area was 0.5 cm2/m2.The physician noted there was severe patient prosthetic mismatch from the structurally normal 23 mm s3u tavr valve.The sapien 3 ultra valve was explanted and replaced with a surgical heart valve.During the procedure nicks root enlargement with pericardial patch was also performed.

Manufacturer Narrative

Updated b.5, b.7 and h.6 device code based on medical records received.Patient prosthesis mismatch (ppm) has typically referred to a situation in which the effective valve area after surgical valve replacement is less than that of a normal human valve.In the aortic position, severe ppm is defined by an indexed effective orifice area of <0.65 cm2/m2, and the incidence of severe ppm after surgical aortic valve replacement ranges between 2% and 20%.According to the literature review, it has been suggested that predictors of ppm after surgical aortic valve replacement include older age, female sex, hypertension, diabetes mellitus, renal failure, larger body surface area, larger body mass index, and the utilization of a bioprosthesis.Furthermore, the presence of ppm is prognostically important because ppm results in higher valve gradients and increased perioperative and overall mortality.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest the sapien 3 ultra valve may have been too small for the patient, which may have caused or contributed to this event.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 this adverse event is not required 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 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.

Manufacturer Narrative

The valve was not returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to post implant increased gradients due to patient prosthesis mismatch.During manufacturing of the sapien 3 ultra transcatheter heart valve, the valve and components are 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.The ifu was reviewed.Physicians are warned that incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, residual gradient (patient prosthesis mismatch) and/or annular rupture.Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography.Device explant is listed as an additional potential risk associated with the use of the valve, delivery system, and/or accessories.No ifu/training deficiencies were identified.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.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 post-implantation increased gradient from patient prosthesis mismatch was confirmed based on the provided medical record.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 ultra 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.Patient prosthesis mismatch (ppm) has typically referred to a situation in which the effective valve area after surgical valve replacement is less than that of a normal human valve.In the aortic position, severe ppm is defined by an indexed effective orifice area of <0.65 cm2/m2, and the incidence of severe ppm after surgical aortic valve replacement ranges between 2% and 20%.According to the literature review, it has been suggested that predictors of ppm after surgical aortic valve replacement include older age, female sex, hypertension, diabetes mellitus, renal failure, larger body surface area, larger body mass index, and the utilization of a bioprosthesis.Furthermore, the presence of ppm is prognostically important because ppm results in higher valve gradients and increased perioperative and overall mortality.As reported, ''tee performed 2 years, 3 months post tavr indicated the 23mm s3u valve was well seated in the lvot.The valve was structurally normal with normal leaflet motion.There was severe patient prosthetic mismatch.The aortic valve peak velocity was 4.0 m/s.The aortic valve mean gradient was 37.4 mmhg, valve area by planimetry was 1.12 cm2 and indexed aortic valve area was 0.5 cm2/m2.The physician noted there was severe patient prosthetic mismatch from the structurally normal 23 mm s3u tavr valve''.Due to insufficient information, the underlying reason for patient-prosthesis mismatch is unknown for this time.

• Brand Name: 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 way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15993028
• MDR Text Key: 305582867
• Report Number: 2015691-2022-10060
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)220315
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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: 03/15/2022
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 01/27/2023
• Supplement Dates FDA Received: 01/09/2023; 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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 Sex: Female