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

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Investigation is ongoing.

Event Description

As reported, during a tf tavr case the first valve (sn 7488109) was implanted however post deployment severe ai was observed and the patient started decompensating.A second valve (sn (b)(4)) was successfully deployed inside the failed valve as a bail out and the patient recovered.Suspected root cause was a frozen 29mm s3 valve leaflet post deployment of the first valve, however a short axis view was not performed to confirm or deny this.There was no wire or catheter across the valve which would have promoted central ai.After the viv the regurgitation was reduced to none/trace.

Manufacturer Narrative

The valve remains implanted in the patient.Additionally, no imagery was provided with the complaint.A dhr review was performed and did not reveal any manufacturing related issues that would have contributed to this complaint.A lot history review did not reveal any other similar complaints.The events were unable to be confirmed; therefore, a complaint history review is not required.The ifu, device preparation training manuals, and procedural training manual were reviewed for instructions relating to the complaint event.During post deployment thv assessment, the physician is instructed to assess the thv post-deployment using fluoroscopy.Withdraw the delivery system from the thv before assisting.Perform an aortogram with the wire still in the lv to assess thv position and complete expansion, patency of coronary arteries, functional assessment of the thv, and annular and aortic integrity.A stiff wire tends to exacerbate central ar.Typically final deployed thv position will be around 70/30 to 80/20 (aortic/ventricular) when using optimal initial thv positioning where the center marker is within the optimal initial center marker zone.Anatomy (stj, calcification, coronaries, etc.), % area sizing, thv size and foreshortening/ inflation volume should also be considered when initially positioning the thv.Waiting some time may help in assessing final pvl.Assess the thv post-deployment using tee in multiple planes: long axis (check for severity of ar and check thv position relative to coronary arteries), short axis (check central vs.Paravalvular regurgitation), malposition and ar.Deep gastric view is best for assessing thv gradients.In order to manage significant central aortic regurgitation, determine etiology (leaflet mobility: manipulation of the leaflet with a diagnostic catheter and leaflet coaptation mismatch: consider converting to open heart surgery) and mechanical support (iabp) not effective with severe ar.Based on the review of the ifu and training manuals, no deficiencies were identified.During manufacturing of the sapien 3 transcatheter heart 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 events were unable to be confirmed.Due to the unavailability of the device and/or relevant imagery, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr and lot history, revealed no indication that a manufacturing non-conformance contributed to the complaint.Additionally, a review of manufacturing mitigations supports that proper inspections are in place during the manufacturing process to detect issues relating 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.Per the ifu, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and transcatheter heart valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to immobile leaflet and central regurgitation including malposition of the valve, impingement of a leaflet due to the calcification, over inflation of the deployment balloon, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All these factors have the potential to contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central aortic insufficiency.As reported, ¿suspected root cause was a frozen 29s3 valve leaflet post deployment of the first valve, however we did not do a short axis echo view to confirm or deny this.There was no wire or catheter across the valve which would have promoted central ai.¿ due to insufficient of information, a definitive root cause was unable to be determined 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.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.No manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.Additionally, no product non-conformance was identified, therefore a product risk assessment is not required.

• 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: 10843896
• MDR Text Key: 216375967
• Report Number: 2015691-2020-14420
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 9600TFX29A
• Device Lot Number: 7488109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR