MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26A

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, a 26mm sapien xt valve was implanted in a 23mm conduit in the pulmonic position via transfemoral approach.Post deployment, the xt valve embolized into the right atrium.A 29mm sapien 3 valve was then successfully implanted in the conduit.  attempts were made to remove the embolized sapien xt valve percutaneously, but were unsuccessful.The patient was converted to surgery and the embolized valve was removed safely.Per report, the sapien xt migrated during inflation into the right ventricular outflow tract (rvot), resulting in the valve becoming unstable from the landing zone and embolizing.  there was no ew device malfunction.  the patient is doing well.

Manufacturer Narrative

Per the instructions for use (ifu), device malposition requiring intervention and device embolization are known potential complications associated with the transcatheter pulmonic valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, movement of the delivery system by the operator, valve size mismatch, suboptimal implant location, and incomplete frame expansion.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 xt 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 deficiency contributed to this adverse event.Per report, the valve and balloon moved during deployment due to anatomy resulting in the valve landing in an unstable position and subsequently embolizing into the right atrium.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; therefore no further actions are required.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.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to field d2 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 9246645
• MDR Text Key: 166944599
• Report Number: 2015691-2019-03993
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 9300TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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 Sex: Female