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

Model Number 9600TFX29A

Device Problem Material Deformation (2976)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device is not returning.

Event Description

As reported by a field clinical specialist (fcs), during first phase of alignment of a 29 mm sapien 3 valve in the aortic position via transfemoral approach, the left ventricle (lv) wire position was lost and re-crossing the native valve was unsuccessful.It was decided to remove the system and re-cross with a straight wire and catheter.Upon attempting to remove the valve and delivery system, the valve began to flair the proximal end of the valve on the tip of the sheath.The procedure was stopped and a cutdown of the right femoral artery was performed to remove the valve surgically.The procedure continued using left femoral artery and valve was successfully implanted without event.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.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: patient's right access vessel had present of calcification, tortuosity.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 unable to be confirmed due to unavailability of returned device.A review of the dhr 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.In this case, ''upon attempting to remove the valve and delivery system, the valve's frame began to slightly bend outwards, or flare the proximal end of the valve on the tip of the sheath''.Per training manual, ''do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again''.Per 3mensio, the patient's access vessel had presence of calcification and tortuosity.The presence of calcification and tortuosity can create challenging pathway during delivery system withdrawal, leading to resistance.In this case, it is possible the crimped valve was not aligned with the sheath and the valve strut was caught at the sheath tip during the valve retrieval through the sheath.If excessive force was used to retrieve the valve while the strut was caught at the sheath distal tip, excessive force can bend the strut on the outflow side.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, withdrawal of crimped valve) 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: 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: 18125764
• MDR Text Key: 329219075
• Report Number: 2015691-2023-17464
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)260207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 1
• 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: 12/20/2023

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: 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: 10/23/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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