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

Model Number 9000TFX26

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 01/31/2014

Event Type  Injury  

Event Description

As reported, a 26mm sapien valve was explanted 43.5 months after implant due to being severely calcified.

Manufacturer Narrative

The explanted valve was returned to edwards irvine for evaluation.Investigation of the event is ongoing, pending evaluation of the return device.

Manufacturer Narrative

Per the instructions for use (ifu), structural valve deterioration (including calcification, thickening, and stenosis) is a potential risk associated with bioprosthetic heart valves.The ifu also includes the following precaution: ¿long-term durability has not been established for the bioprosthesis.Regular medical follow-up is advised to evaluate bioprosthesis performance¿.Heavy calcification was observed in the cusp areas, free margin and commissures of the returned valve.There was also moderate host fibrotic tissue (pannus) overgrowth encroached onto the tissue at the inflow aspect.2 of the leaflets were fused at the commissural area by the pannus tissue from the outflow view perspective.The leaflet calcification was evident in the x-ray imaging of the valve as received.The report of calcification was confirmed in the returned sample, but no manufacturing defects were identified during the device evaluation.Due to the unavailability of the patient¿s medical history, it is unknown if there are other medical conditions that could have contributed to the calcification formation on this particular sapien valve.Leaflet tissue calcification is one of the most common failure modes for bioprosthetic heart valves and is highly variable among the patients.The direct root cause for the leaflet calcification in this particular valve remains unknown.The underlying mechanism of bioprosthetic tissue calcification is not fully understood.It is generally believed that patient biological factors and preexisting medical conditions may play significant roles in the development of bioprosthetic valve calcification, including: patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.Since no manufacturing nonconformances, labeling or ifu inadequacies have been identified, no corrective or preventive action is required at this time.

Manufacturer Narrative

Preliminary evaluation results: during a visual inspection it was observed that the returned valve has severe calcification and patient ingrown tissue.The valve appeared to be mis-shapened due to explant procedure.The investigation is still ongoing.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3658327
• MDR Text Key: 4284387
• Report Number: 2015691-2014-00510
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2010
• Device Model Number: 9000TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 03/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2014; 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2009
• 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: 76 YR