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

Model Number 9750TFX23

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from our affiliates in greece.As reported, this was a case of a 23mm sapien 3 ultra valve, in aortic position by transfemoral approach.During the procedure, the valve was implanted low (50/50) due to pacing issues (turning on and off).It was realized that there was blood turbulence above the valve.Therefore, the decision was made to undergo a valve-in-valve procedure.A second valve was implanted 70/30.As medical opinion, both malpositioned valves were related to the pacing issues.In addition, it was reported by the physician that during the implant of both valves, some tension was noted from the ventricle, but were attributed to patient factors.The final patient outcome was good.

Manufacturer Narrative

The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been r eviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for unknown valve regurgitation was unable to be confirmed due to unavailability of medical records and/or applicable imagery.Available information suggests that patient factors (malpositioned thv) likely contributed to the event as the valve was implanted low (50/50) due to pacing issues.In this case, valve malpositioned toward ventricular, which could result in the native leaflets hanging over and covering the outflow of the deployed valve.This could result in reduced coaptation of the leaflets and central regurgitation.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.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.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest that patient or procedural factors (pacing issues & guidewire tension) 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.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 18810623
• MDR Text Key: 336588477
• Report Number: 2015691-2024-01464
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• 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: 90 YR