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

Model Number 9600TFX

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2022

Event Type  Injury  

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 4 2022 data extract for mitral serious injury events for the sapien 3 valve.This report summarizes 4 cardiac surgery or intervention - other unplanned serious injury events for the sapien 3 transcatheter heart valve.The age range for this event is 71-86 years.The breakdown for gender is as follows: 3 females and 1 male.

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number (b)(4) and summarizes 4 cardiac surgery or intervention - other unplanned serious injury events for the sapien 3 transcatheter heart valve in the mitral position.The "time to event" (tte, in days) for this event was 3.5.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).The instructions for use (ifu) list reoperation, including emergency cardiac surgery, as additional potential risks associated with the use of the thv, delivery system, and/or accessories.This event type (unplanned other cardiac surgery or intervention) is defined as: the patient subsequently underwent other types of cardiac surgery or cath lab interventions (not otherwise specified) that was unplanned.This could include reoperation for damage to adjacent structures, or potentially valve explant related to embolization, or other event types.Cardiovascular injury, including perforation or dissection of valvular structures and valve embolization requiring intervention are known potential complications listed in the product instructions for use (ifu).Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valves (thv).Training includes proper guidewire positioning, and careful manipulation of devices.Per the thv ta training manuals, after gaining lv access with the 0.035" soft guidewire, the wire should be jiggled under tee imaging of the mitral valve.An increase in mr suggests wire entanglement in the mitral sub-valvular apparatus.If entanglement is suspected, the guidewire should be completely removed from the ventricle; the operator should change direction of the needle and reinsert the guidewire into the ventricle, checking again for wire entanglement.The tf training manual also provides guidance for valve crossing and wire exchange: exchange 0.035" amplatz extra-stiff wire with pre-shaped distal end in left ventricle.Ensure the guide catheter is advanced upon wire exchange to ensure exchange wire does not get caught in the mitral chordae.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.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.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 to 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 this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16023220
• MDR Text Key: 305978525
• Report Number: 2015691-2022-09812
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: E2016006
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 78 YR