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

Model Number 9300TFX26A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Regurgitation, Valvular (2335)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards field clinical specialist, approximately 6 years and 6 months post implantation of a 26mm sapien xt valve in the aortic position via transfemoral approach, a non-edwards valve was placed inside the existing valve due to a 'flailing' leaflet.Per echo report, there is moderate aortic valve regurgitation noted.Av peak/mean gradient 25/13mmhg.

Manufacturer Narrative

Since the valve remains implanted in the patient it was not available to be returned for evaluation.No imagery was provided for review.A device history review dhr was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the reported event.During manufacturing the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.Instructions for use ifu for sapien xt with novaflex plus us was reviewed for instructions relating to the complaint event.Precautions long term durability has not been established for the valve.Regular medical follow up is advised to evaluate thv performance.Potential adverse events additional potential risks associated with the use of the valve delivery system and or accessories include structural valve deterioration wear fracture calcification leaflet tear tearing from the stent posts leaflet retraction suture line disruption of components of a prosthetic valve thickening stenosis.No ifu deficiencies were identified.As the reported event was unable to be confirmed a complaint history review is not required.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure additional assessment of the failure mode is not required at this time.Since no product non conformances or ifu training deficiencies were identified during evaluation a product risk assessment escalation is not required.Since no manufacturing nonconformances or ifu deficiencies were identified corrective action is not required.The reported event was unable to be confirmed as relevant images or the device were not provided for evaluation.A review of dhr lot history and manufacturing mitigations did not provide any indications that a manufacturing nonconformance would have contributed to the complaint.Additionally a review of the ifu and training manual revealed no deficiencies.During the manufacturing process all sapien 3 valves are 100 percent visually inspected for defects and 100 percent tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, approximately 6 years and 6 months post implantation of a 26mm sapien xt valve in the aortic position via transfemoral approach a nonedwards valve was placed inside the existing valve due to a flailing leaflet.During the manufacturing process all sapien xt valves undergo multiple inspections for leaflet appearance defects and 100 percent tested for proper coaptation under physiological backpressure conditions prior to release for distribution.The reported event was noted 6 years and 6 months after valve implantation which was well beyond the durability duration assessed for sapien xt valve required by fda guidance and iso standard for bioprosthesis valve 200 million cycles of accelerated wear testing awt which is equivalent to 5 years of durability therefore it is unlikely that a manufacturing defect or device malfunction contributed to the event.Additionally per device ifu structural valve deterioration leaflet tears is a potential adverse event.Due to insufficient information a definitive root cause is unable to be determined at this time.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11385883
• MDR Text Key: 233790644
• Report Number: 2015691-2021-01514
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: 9300TFX26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention