MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body Embolism (4439)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter pulmonic valve replacement (tpvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to pulmonic embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified pulmonic leaflets, preserved ejection fraction, loss of pacing capture, 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 3 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 aortic embolization (i.E.Minimal leaflet calcification, severe septal hypertrophy), 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.Investigation results suggest possible interaction between the delivery system balloon and the deployed valve during withdrawal of the delivery system may have contributed to the initial movement of the deployed valve.The attempts to recapture and reposition the valve likely contributed to the embolization into the rvot and subsequent explant and surgical repair of the pulmonic valve.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

During a transcatheter pulmonary valve replacement (tpvr) procedure, post deployment, the sapien 3 valve embolized.As reported, a 29mm sapien 3 valve was prepared with nominal plus 3cc of inflation fluid.The valve was deployed in a pre-existing transannular patch in the pulmonic position.The valve landed 'perfectly' at the waist, which measured 25mm to 26mm.No paravalvular leak (pvl) was observed.Upon attempting to retrieve the delivery system inflation balloon from the valve, the valve 'slipped down'.During the attempt to capture and reposition the valve, the valve slipped down into the rvot.The patient was transferred to surgery.The valve was explanted, and the pulmonic valve was surgically repaired.At the time of the report, the patient was in stable condition.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11925879
• MDR Text Key: 254075843
• Report Number: 2015691-2021-03278
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)220909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

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: 09/09/2022
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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 Age: 10 YR