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

Model Number 9600TFX23

Device Problems Incomplete Coaptation (2507); Defective Device (2588)

Patient Problems Aortic Regurgitation (1716); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6), two days post tavr with a 23 mm sapien 3 valve in a 23mm non edwards valve (viv) in the aortic position, severe aortic regurgitation was noted.The sapien 3 valve was replaced on post-operative day (pod) 2.The explanted sapien 3 valve showed two leaflets with no movement.The valve was discarded by the site.

Manufacturer Narrative

The valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.  in addition, no imagery was provided by the site.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.During manufacturing, the sapien 3 valves are 100% visually and dimensionally inspected for any defects.The adequacy of thv valve coaptation and valve appearance are 100% inspected.Prior to final packaging, 100% visual inspection is performed at preliminary packaging to ensure no damage to the valve.  these manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  the occurrence rate did not exceed the august 2019 control limits for applicable trend category. a review of the instruction for use (ifu) and training manual revealed no deficiencies.  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.The complaint for valve regurgitation was unable to be confirmed, as no relevant procedural video/imagery were provided.In this case, despite request, no information regarding valve performance immediately post implantation was not available.Per report, the sapien 3 valve was explanted on pod2 due to aortic regurgitation, and post removal, the sapien 3 valve showed two leaflets with no movement.The valve frame could have been damaged from the explant, restricting the leaflets from coaptating properly.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.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.Furthermore, records indicate that all frames released for production built had 100% passed for both visual and dimensional inspections during receiving inspections.As such, the complaint being the result of a manufacturing nonconformance is unlikely.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the valve annulus, uneven distribution of calcium on the valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.Patient anatomy information was not given in this case, and without imagery, engineering was unable to visualize the final positioning and expansion of the valve, as well as unable to determine if the leakage was a paravalvular leak (pvl) or central regurgitation or both.There is insufficient information at this time to determine a root cause.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9050786
• MDR Text Key: 161256072
• Report Number: 2015691-2019-03443
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 9600TFX23
• 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: 77 YR