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

Model Number 9750TFX23

Device Problem Material Deformation (2976)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was discarded.

Event Description

As reported, it was a case of an implant of a 23mm sapien 3 ultra valve, in aortic position by transfemoral approach.During insertion of the commander delivery system through esheath, it was observed that the valve got stuck after the hub of esheath and was not possible to advance.It was decided to withdraw the system as a single unit.After the withdrawal, it was noted that the valve puncture the hub of esheath.A new kit was prepared and the procedure was performed successfully.There was no harm to the patient and the final patient outcome was good.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: valve seems to be stuck after hub of esheath.One (1) bent strut outwards exposed through the strain relief.During manufacturing, the device undergoes multiple 100% inspections.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed based on provided imagery.A review of the dhr, lot history, complaint history, and manufacturing mitigation 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 loader was inserted but, when it was tried to insert the commander ds through esheath, it was observed that the valve got stuck after the hub of esheath and was not possible to advance.It was decided to withdraw it as a single unit.After the withdrawal, a perforation after the hub of esheath, caused by the valve''.Also ''as per medical opinion, the root cause of this event might be that the loader was far proximal when it was introduced the commander ds and, as this area was not protected by loader, the perforation occurred''.Per the ifu and training manual, the loader must be completely inserted into the sheath before delivery system and valve insertion.The loader is used to facilitate a smooth transition of the crimped valve through the sheath hub.If the loader was not inserted through the sheath properly, the crimped valve can be exposed and interact with the hemostasis valves within the sheath hub resulting in frame damage to the inflow of valve.In this case, it's reported that the loader was partially pulled back during delivery system and valve insertion through the sheath.It is possible that the valve struts at the outflow interacted with the sheath liner during the delivery system insertion which resulted in the sheath puncture, bent strut at the inflow side.As such, available information suggests that procedural factors (improper loader use) 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 17831171
• MDR Text Key: 324453238
• Report Number: 2015691-2023-16212
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: 9750TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: 80 YR
• Patient Sex: Female