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

Model Number 9600TFX26A

Device Problems Off-Label Use (1494); Device Slipped (1584); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Injury (2348); Aortic Dissection (2491)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Udi reference number: (b)(4).Investigation is ongoing.

Event Description

As reported, during a transfemoral valve in valve (sapien 3 in non-edwards valve) tavr procedure, post deployment of the sapien 3 valve, echo showed the valve was position too ventricular, which resulted in severe central ai of the native aortic valve.  a second valve was deployed which reduced the central ai to none. off-label commercial case. initially the patient had a mi with left-main stent placement and placed on ecmo with an impella left ventricle assist device.  when the impella device was removed, a native aortic leaflet was torn causing severe ai.  the plan was then to use a non-edwards tavr heart valve and ¿anchor¿ it in with a sapien 3 valve since there was no aortic stenosis/calcium.  once the 29mm non-edwards heart valve was deployed, it immediately slipped down into the ventricle (wide part of the non-edwards valve was in annulus).The operator tried to snare the non-edwards heart valve back into place but was not successful.  it was perceived that the non-edwards heart valve was too oversized to be pulled back.  a 26mm sapien 3 was then deployed within the waste of the non-edwards heart valve, which was in the lvot/ventricle, all while pulling the valve aortic.  after deployment, tension was released on the snares and the non-edwards heart valve slipped back down to the lvot.  the sapien 3 valve was now too ventricular, not capturing the native aortic valve and correcting the severe central ai.     a decision was made to place a second 26mm sapien 3 valve more aortic to capture the native valve.  the base of the second sapien 3 valve was touching the top of the first sapien 3 valve.  both sapien 3 valves were within the non-edwards valve.  the second valve was placed without issue and the native central ai resolved to none.  the patient was noted to have left the room in stable condition.Additional information provided, however, indicated the patient developed a hemorrhagic stroke while on heparin and has subsequently expired.

Manufacturer Narrative

The valve was not returned to edwards lifesciences as it remains implanted in the patient.  multiple attempts to obtain relevant images of the case were made, however, the images were not provided.   per the instructions for use (ifu), valve malposition requiring intervention is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction (stj), 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 malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, there was no allegation or indication a product deficiency malfunction contributed to this adverse event.  per report, the sapien 3 valve was deployed in a too ventricular position due to patient factors (no annular calcification) and procedural factors (sapien 3 valve was deployed within the waste of the non-edwards heart valve, which was in the lvot/ventricle.  after deployment, the non-edwards heart valve slipped back down to the lvot which caused the sapien 3 valve to be positioned too ventricular) 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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8599514
• MDR Text Key: 144750796
• Report Number: 2015691-2019-01668
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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 Expiration Date: 11/16/2020
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 07/23/2020
• Supplement Dates FDA Received: 06/13/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR