MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problem Material Deformation (2976)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.Device discarded.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tmvr in a 29mm non-edwards valve, there was resistance between the valve/delivery system and the esheath.The stent strut of the sapien 29mm valve was protruding out and got caught in the esheath plus halfway through advancement.The valve was wasted.The entire system was removed, and a new valve and delivery system were used successfully.There was no patient harm.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.The device history record (dhr) review 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 this event.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.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 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 frame damage 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, ''during a transfemoral tmvr in a 29mm non-edwards valve, there was resistance between the valve/ds and the esheath.The stent strut of the 9600tfx 29mm valve was protruding out and it got caught in the esheath plus half way through it'' per 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''.Additionally, per case note, the patient's access vessel had some degree of tortuosity.The presence of tortuosity can create a challenging pathway during delivery system advancement, leading to resistance.If excessive force was used overcome associated navigation difficulties, it could have caused the frame struts to physically interact with esheath, resulting in the bent strut seen at outflow.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the complaint event.No ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective/ or preventative actions nor product risk assessment (pra) are required at this time.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 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 15219794
• MDR Text Key: 302723572
• Report Number: 2015691-2022-07305
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250119
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: Female