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

Model Number 9600TFX29A

Device Problem Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 09/14/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2023-16570.The investigation is ongoing.H3 other text : the device was not returned for evaluation.

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 valve in the aortic position the 16f esheath was placed in rcfa.The vessel had noted severe tortuosity.The valve and the 29mm commander delivery system were placed into the sheath and advanced.Resistance noted with advancement of catheter.Fluoro assessment of sheath and device noted the valve appeared outside sheath in common iliac.The team attempted to withdraw commander and valve but resistance was noted and the decision was made to withdraw entire system as unit.Unit withdrawn and a new 16f esheath was inserted.Bleeding noted from site coda balloon place through contra side of the sheath.Coda inflated and perforation noted at external iliac.Multiple stents were placed to establish flow to leg.Per the fcs, the valve did not exit the tip of the sheath.The sheath was split along the seam 4cm or so and there was a bent valve strut.There were no abnormalities noted with the sheath prior to use.The loader was able to be inserted into the sheath/sheath housing.The sheath was not inserted at a steep angle and the expansion tool was not used.The delivery system was at the partially expandable blue portion when resistance was noted.The perceived root cause of the iliac perforation was the valve through the sheath.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The complaint for frame damage was unable to be confirmed due to unavailability of returned device/relevant imagery.A review of the dhr 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 the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, ''the vessel had noted severe tortuosity.The valve and the 29mm commander delivery system were placed into the sheath and advanced.Resistance noted with advancement of catheter'' and ''fluoro assessment of sheath and device noted the valve appeared outside sheath in common iliac.'' also, ''the valve did not exit the tip of the sheath.The sheath was split along the seam 4cm or so and there was a bent valve strut.'' 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''.Per imaging evaluation, the patient's right access vessel had presence of calcification and tortuosity.The presence of calcification and tortuosity can create challenging pathway during delivery system advancement, leading to resistance.In this case, it is possible difficulty was encountered during delivery system advancement and additional manipulation was applied to overcome the resistance.If excessive force is applied to manipulate the device, it can lead to the valve struts tearing through the sheath shaft and result in the reported bent valve strut.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the complaint event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective nor preventative actions (pra) are required.

• Brand Name: EDWARDS SAPIEN 3 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: 17878899
• MDR Text Key: 325017692
• Report Number: 2015691-2023-16571
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)260403
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male