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

Model Number 9600TFX29A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Vascular System (Circulation), Impaired (2572)

Event Date 11/29/2019

Event Type  Death  

Manufacturer Narrative

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, such as the mitral apparatus, or potentially valve explant related to embolization, or other event types.  cardiovascular injury, including perforation or dissection of valvular structures [e.G.Injury to the mitral valve/ apparatus], and valve embolization requiring intervention are known potential complications listed in the product instructions for use (ifu).  chordae tendinae rupture in tavr can occur during advancement of the guidewire, bav catheter, or delivery system and is most likely to occur with antegrade approaches, however, can occur with a retrograde approach.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 guidecath 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, a narrow, calcified sinotubular junction, minimally or bulky/severely calcified aortic leaflets, 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 patients with high-risk anatomical features for ventricular embolization (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, specific procedural details are not available to determine potential contributing factors, or if the event is related to an edwards device.  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.The device identification (di) number is (b)(4).

Event Description

Per the information received from the thv/tvt registry for (b)(6) 2020 data extract for mitral deaths for the sapien 3 transcatheter heart valve, a (unplanned other cardiac surgery or intervention) occurred, and the patient expired.No additional information is available for this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10405780
• MDR Text Key: 202857958
• Report Number: 2015691-2020-13116
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR