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

Model Number 9755RSL23A

Device Problem Material Deformation (2976)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 23mm sapien 3 ultra resilia, there were 3 stent struts noted to be bent back after crossing the annulus.It as decided to proceed with deployment.The patient went into v fib arrest, and coded.Once the patient was stabilized, echo showed the valve was in good position with no paravalvular leak and no pericardial effusion.The devices were removed with no issues.The patient was transported to icu in semi stable condition.Per imaging received, the valve struts corrected itself during deployment.Per report, when the patient was intubated prior to the tavr procedure starting, before obtaining access, the patient began to desaturate and coded.The patient was in pea, and compressions were started.At this point, femoral access was gained to proceed with the tavr procedure.After the wires crossed the annulus, bav was performed, the patient's pressure was extremely elevated due to medications that had been given.The procedure advanced in order to quickly proceed with tavr.There was difficulty with ventilation and the patients o2 saturations remained below 60.A 23mm valve was prepped and inserted for deployment.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The provided imagery was reviewed, and the following was observed: three (3) struts were bent on crimped valve at inflow side.The valve struts corrected itself during deployment.The instructions for use/training manuals were reviewed for guidance/instruction involving the devices.Based on the review of the ifu/training manuals, no deficiencies were identified.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 for frame damage was confirmed from provided imagery.As reported, 'during a transfemoral tavr procedure with a 23mm sapien 3 ultra resilia, there were 3 stent struts noted to be bent back after crossing the annulus.It as decided to proceed with deployment'.In addition, per provided information, it is likely the loader was not fully inserted inside the sheath.Per training manual, 'insert the loader into the sheath until the loader stop'.The loader is used to facilitate a smooth transition of the crimped valve through the sheath hub and proximal strain relief.The incomplete loader advancement can lead the valve to get caught within the sheath during delivery system insertion, which may lead to bent struts.In this case, because the loader was not fully inserted inside the sheath, this may increase the interaction between the crimped valve and the sheath, causing the damage to the struts on the inflow side.As such, available information suggests that use error (incomplete loader advancement) may have contributed to the complaint event.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: 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: 17760603
• MDR Text Key: 323725938
• Report Number: 2015691-2023-15992
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215809
• UDI-Public: (01)00690103215809(17)260208(11)2302092110271226
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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: 9755RSL23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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 Age: 44 YR
• Patient Sex: Male