MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

Edwards received notification from a field clinical specialist that a patient underwent a transfemoral tavr.As reported, the valve strut bent backwards in esheath during advancement.There was no resistance between the valve/ds and the esheath noted.The device was removed.A second device was prepped and implanted successfully.There was damage noted on the 1st esheath.It was split/pierced at the distal tip.There were no patient injuries.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-01123.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined for any abnormalities and the following was observed.Crimped valve: one (1) strut bent on the inflow side.Three (3) struts exposed through skirt, normal after manipulation during insertion through sheath.Expanded valve: one (1) strut remains bent.Three (3) struts remain exposed through skirt.Frame is canted and deformed.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.The complaint of valve frame damage was confirmed based on evaluation of the returned device and imagery.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''the valve strut bent backwards in esheath during advancement''.Procedural fluoroscopy shows an inflow valve strut bent outwards within the sheath.Per the training manual, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification'', ''if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system'', and ''do not over-manipulate the sheath at any time''.Per 3mensio, the patient has calcification and tortuosity in the access vessels.Calcification and tortuosity can result in the creation of sub-optimal angles during delivery system insertion that may lead to increased interaction between the valve and the inner lumen of the sheath.In this case, excessive device manipulation or high push force can lead to the valve struts interacting with the sheath and result in the frame damage at the valve inflow side.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation is required.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18723630
• MDR Text Key: 336090114
• Report Number: 2015691-2024-01124
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755RSL29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2023
• 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 Sex: Male