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

Model Number 9600TFX23

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2022

Event Type  Injury  

Event Description

As reported, it was a case of a 23 mm sapien 3 valve, on aortic position by transfemoral approach.During the procedure, the prosthesis was implanted in high position with aortic insufficiency of 3/4.As a consequence, a second valve was implanted and the event was resolved.

Manufacturer Narrative

The investigation is ongoing.H3 other text : the valve remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information and correction from information from the site and from a a product investigation.The following sections of this report have been updated: b.4, b.5, g.3, g.6, h.2 and h.6.The following sections of this report have been corrected: h.6 device code (replacing 1250 with 14547).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.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the landing zone, uneven distribution of calcium on the landing zone, bulky or severe calcification, a landing zone with an elliptical shape, and valve under or oversizing.Edwards extensively trains physicians before they are qualified to use the sapien thv (all models).The thv training manuals instructs the operator on proper imaging screening requirements, including the use of good quality echocardiography and/or computed tomography (ct) to appropriately measure the landing zone, assess the content and distribution of calcium, and other patient anatomical factors.Multiple imaging modalities should be considered during valve size selection.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including patients screening and procedural considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures are also included.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to malposition, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, minimally or bulky/severely calcified leaflets, preserved ejection fraction, significant landing zone calcification, loss of pacing capture, rapid deployment, the release of stored tension during deployment, inaccurate measurement of the landing zone, a landing zone with an elliptical shape, and valve under or oversizing.Additional risk factors in aortic position include a narrow sinotubular junction and severe septal hypertrophy.The ifu cautions that incorrect sizing of the valve may lead to paravalvular leak, migration, or embolization.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv (all models).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor in the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for malposition or embolization, a balloon valvuloplasty may indicate potential balloon movement during valve deployment.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors (rapid deployment) 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

Event Description

Per additional information received, the aortic insufficiency reported was confirmed to be paravalvular leak.

• 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: 18959897
• MDR Text Key: 338368556
• Report Number: 2015691-2024-02218
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: 12/05/2023
• Device Model Number: 9600TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 68 KG