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

Model Number 9600TFX26A

Device Problem Migration (4003)

Patient Problem Heart Failure (2206)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter aortic valve replacement.According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the aortic wall.Stent valves are subjected to antegrade ejection forces during systole.Less-than-severe and non-uniformly distributed calcification of the native leaflets, incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.Additionally, residual overhanging leaflets can exert downwards force during diastole, causing migration of the thv towards the left ventricle.The edwards thv patient screening manual advises the operator on pre-procedure assessment of the aortic valve and root, taking into consideration the degree and distribution of native leaflet calcification.The procedural didactic instructs 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 transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct sizing, alignment and positioning of the device are emphasized as key factors to the placement and fixation of the device.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The root cause of the event remains indeterminable but may have been impacted by patient and procedural related factors.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

Edwards received notification from a field clinical specialist that at 1 year and 5 months, a patient with a 26 mm sapien 3, implanted in the aortic position (90/10 aortic/ventricular), underwent a valve in valve procedure due to migration.The patient was symptomatic for heart failure. aortography revealed aforementioned s3 had migrated (30/70 aortic/ventricular). a new sapien 3 ultra was prepared and deployed in good position.The patient was stable post procedure and sent to recovery.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• 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: rene dorne ; 1 edwards way; linc 4-1; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10604342
• MDR Text Key: 209163804
• Report Number: 2015691-2020-13781
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Date Device Manufactured: 01/16/2019
• 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 Age: 72 YR