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

Model Number 9750TFX26A

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by a field clinical specialist, during a procedure for a 26 mm sapien 3 ultra valve in the pulmonic position by transfemoral approach, the valve 'missed the landing zone' and moderate perivalvular leak was observed post deployment.A second valve was implanted distal to the first valve placement with good results.

Manufacturer Narrative

Sending final submission.No further information was obtained.Correction to h6: type of investigation, investigation findings and investigation conclusions.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event 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 aortic malposition, 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 aortic leaflets, preserved ejection fraction, significant mitral annular calcification (mac), loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Deployment of the sapien valve too aortic has the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency; it can obstruct the coronary ostia; and lead to embolization of the prosthesis into the ascending aorta.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 aortic malposition (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/indicate the valve missed the landing zone due to improper positioning prior to deployment.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.H3 other text : device not returned.

Manufacturer Narrative

Change d2 to pulmonic valve, prosthesis, percutaneously delivered.Change pc to npv and g4 pma# to p200015.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 d2 and g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONIC 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: 12006443
• MDR Text Key: 256450015
• Report Number: 2015691-2021-03611
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230118
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/18/2023
• Device Model Number: 9750TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male