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

Model Number 9750TFX26

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  Injury  

Event Description

The medical article ''valve-in-valve-in-ring: a bailout strategy to tackle paravalvular leaks due to device malapposition'' was reviewed.During the review it was noted that a 55-year-old male underwent a mitral valve-in-ring transfemoral percutaneous procedure with a 26mm edwards sapien 3 ultra valve.After the valve was released, severe paravalvular leak coming from the lateral side was observed, possibly due to the high position of the sealing skirt in the lateral portion of the stented valve.To promptly tackle this issue, a second valve with further post-dilation was successfully implanted, and the paravalvular leak disappeared.At the end of the procedure, no paravalvular leaks were detected and only a mild increase of the mv mean gradient (8 mmhg) with normal estimated pulmonary pressures was present.

Manufacturer Narrative

Citation: vairo, alessandro, et al.''valve-in-valve-in-ring: a bailout strategy to tackle paravalvular leaks due to device malapposition.'' journal of cardiovascular echography 31.4 (2021): 246.Investigation is ongoing.Valve remains implanted.

Manufacturer Narrative

Corrected h.6 type of investigation, investigation findings, and investigation conclusions.The device was not returned for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.During manufacturing of the sapien 3 ultra 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.Imagery from the article was reviewed and a paravalvular jet was present following thv deployment.It should be noted that the sapien 3 ultra thv was deployed within a pre-existing mitral ring via transfemoral procedure with no details provided about the implant date.Per the ifu, s3u valve with the commander delivery system (ds) was only approved for replacement of native aortic valve due to calcific stenosis in the eu region.Therefore, this was off-label operation.The ifu and training manuals for tf (transfemoral) procedure in the aortic position and were reviewed for relevant guidance for an s3u implant using a commander delivery system.The edwards sapien 3 ultra system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery.Physicians are warned that correct sizing of the thv is essential to minimize the risk of paravalvular leak, migration, and/or annular rupture.Ensure fluoroscopic view used for deployment is the coplanar view where inferior aspect of all 3 cusps are on same plane.If positioning is difficult using fluoroscopy alone, consider using both fluoroscopy and echo.Ensure to pull back the flex catheter prior to thv deployment.Small paravalvular regurgitant jets are common.They are hemodynamically insignificant and may resolve within minutes to hours.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 device problem was identified affecting distributed product, no pra is required.Since no edwards defects were identified, no corrective or preventative actions are required.The pvl was confirmed based on article imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv was deployed in mitral position containing a ring, which is not an indicated use of the sapien 3 ultra thv with a commander ds in the eu region at the time of implantation.Therefore, this was off-label operation.Per reviewed article, patient underwent ''a valve-in-ring transfemoral percutaneous procedure and a 26 mm edwards sapien 3 ultra valve was implanted.After the valve was released, a severe paravalvular leak coming from the lateral side was observed, probably due to the high position of the sealing skirt in the lateral portion of the stented valve.'' per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.In this case, article details indicated that the thv might have been seated too high at lateral site upon deployment.If the final position was too atrial, it would prevent the pvl skirt from properly sealing against target site, leading to the reported paravalvular leak.As such, available information suggests that procedural factors (malpositioned thv) may have contributed to the complaint event.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16343636
• MDR Text Key: 309269247
• Report Number: 2015691-2023-10714
• Device Sequence Number: 1
• Product Code: NPU
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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 Model Number: 9750TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/13/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male