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

Model Number 9600TFX29

Device Problems Obstruction of Flow (2423); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348); Obstruction/Occlusion (2422)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation as the device remains implanted.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential complication associated with the transcatheter valve replacement (tvr) 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 device malfunction contributed to this adverse event.The cause of the malposition is unknown, however may be due to procedural factors (device manipulation) and or the mechanisms described above.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.

Event Description

As reported by the edwards affiliate in (b)(4), during a transseptal tmvr valve in valve (29mm sapien 3 valve in medtronic mosaic 31mm valve) during the last part of inflation, the sapien 3 valve ¿jumped towards the ventricle¿.The deployment was deemed too low by the physicians and the patient¿s blood pressure dropped.The decision was then made to deploy another 29mm sapien 3 valve inside the first sapien 3 valve, in a higher position, however after further discussion the patient was put on ecmo and transferred for surgery instead.The sapien 3 valve was removed and a surgical valve was implanted.The patient was noted be in the icu on inotropes, dialysis.

Manufacturer Narrative

Additional information provided indicated that during the procedure, during inflation, the valve had displaced towards the ventricle resulting in lvot obstruction.  in view of his worsening hemodynamics, he was urgently placed on ecmo and both the edwards and the surgical valve were explanted.  post procedure (over the next few days), the patient¿s condition deteriorated.  the patient required higher doses of inotropes, developed poor peripheral circulation, had anuric renal failure requiring dialysis, developed right pneumothorax requiring re-insertion of chest drain and had vt arrest requiring cpr and cardioversion.  respiratory function initially improved however neurological situation remained poor.  the patient eventually developed an abnormal respiratory pattern.  in review of his advance directive and after discussion with his family, invasive supports were withdrawn and the patient expired on pod12.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7900234
• MDR Text Key: 121435652
• Report Number: 2015691-2018-03902
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 9600TFX29
• 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): Required Intervention
• Patient Age: 82 YR