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

Model Number 9600TFX26

Device Problem Difficult to Open or Close (2921)

Patient Problems Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Citation: chan, kwong-yue eric, et al.''first-in-human undermining iatrogenic coronary obstruction with radiofrequency needle (unicorn) procedure during valve-in-valve transcatheter aortic valve replacement.'' circulation: cardiovascular interventions 15.11 (2022): 928-931.Investigation is ongoing.Device not returned.

Event Description

As reported by the through the review of the medical article from hong kong: ''first-in-human undermining iatrogenic coronary obstruction with radiofrequency needle (unicorn) procedure during valve-in-valve transcatheter aortic valve replacement''.This was a case of an extreme surgical risk patient who underwent transaortic tavr with a 26 mm sapien 3 valve.One year later, the patient was readmitted for acute pulmonary edema.Echocardiography showed elevated mean aortic valve gradient of 45 mmhg, left ventricular ejection fraction of 25% and frozen leaflet and noncoronary cusps.Wafarin was given for suspected leaflet thrombosis but computed tomography did not visualize any leaflet thrombus or calcification but revealed high risk of left coronary obstruction due to low sinotubular junction and virtual valve-to-coronary distance of zero.As a consequence, it was agreed to undergo redo tavr with unicorn technique.There was only transient mild aortic regurgitation through the fenestration as the defect was immediately occluded by the new s3 delivery system, without need for recrossing or guidewire exchange.Finally, intraleaflet implantation of a new 26 mm sapien 3 was performed, lacerating and entrapping the existing leaflet as it expanded.The new prosthesis was implanted low to prevent coronary obstruction should the patient require another valve-in-valve in the future.Post implantation echocardiography reveal mean aortic valve gradient of 5 mmhg with no flail leaflet or aortic regurgitation.

Manufacturer Narrative

Additional information received from the author and added to b.5 and b.7 accordingly.Additional h.6 health effect codes were also added.Investigation is ongoing.

Event Description

A response was received from the author.Prior to the valve in valve procedure, anticoagulants and balloon valvuloplasty were both used in an attempt to resolve the frozen leaflet issue.The implant procedure was performed as per ifu.The patient outcome was good.As per medical opinion, the root cause of the frozen leaflet might be related to the underlying end stage of renal failure on dialysis.

Manufacturer Narrative

Updated h.6 codes.The device wasn't returned for evaluation.During manufacturing of the sapien 3 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 imagery was provided and reviewed; however, there was no relevant imagery was provided to support investigation of this complaint event.Based on the article publication date and approximately 1 year implant duration, the valve was likely implanted in (b)(6) 2021.As an exact implant date is unknown, the first day of the month and year were selected to be used as a reference point for ifu revision.Accelerated deterioration of the thv may occur in patients with altered calcium metabolism.Thv recipients should be maintained on anticoagulant/antiplatelet therapy to minimize risk of valve thrombosis or thromboembolic events, as determined by their physicians.Structural valve deterioration and valve thrombosis are listed as potential risks associated with the transcatheter heart valve implantation procedure, the bioprosthesis, and the use of its associated devices and accessories.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 or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.The motion restricted valve leaflet - in patient complaint was unable to be confirmed as medical record and/or relevant imagery was not returned for evaluation.Since the valve serial number was not available for evaluation, dhr and lot history review were unable to perform to determine the presence of manufacturing nonconformances.A review of the ifu revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% functionally 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 article, ''echocardiography showed elevated mean aortic valve gradient of 45 mmhg, left ventricular ejection fraction of 25% and frozen leaflet and noncoronary cusps.Wafarin was given for suspected leaflet thrombosis but computed tomography did not visualize any leaflet thrombus or calcification''.As per medical opinion, the root cause of the frozen leaflet might be related to the underlying end stage of renal failure on dialysis.It is well known that patients with chronic renal disease is predisposed to bioprosthetic heart valve calcification.Tissue calcification is a very common failure mode of structural valve deterioration (svd), which can manifest in the form of thickened leaflets resulting frozen leaflet or leaflet motion restricted as reported.Although a definitive root cause was unable to determine, it is possible that patient factors (chronic kidney disease) contributed to the reported event.

• 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
• 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: 15947285
• MDR Text Key: 305142193
• Report Number: 2015691-2022-09766
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 01/06/2023
• Supplement Dates FDA Received: 01/04/2023; 01/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female