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

Model Number 9755RSL26A

Device Problem Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : device discarded.

Event Description

As reported by an edwards lifesciences field representative, valve frame damage and subsequent surgical removal of devices occurred.This was a transcatheter aortic valve replacement (tavr) procedure via transfemoral approach.The 14fr esheath+ was inserted into the patient, however, it was more difficult to insert than usual per the operator.Prior to the tavr, a bav was performed.After the bav was withdrawn, the 26mm commander delivery system and 26mm sapien 3 ultra resilia valve were advanced through the sheath.The operator had difficulty advancing the delivery system through the sheath and had to push harder than anticipated.The delivery system and valve punctured through the liner on the side of the sheath.The undeployed valve prolapsed into the contralateral iliac (left) and the delivery system was kinked on itself.The heart team was concerned about creating an emergent situation, so the decision was made to repair surgically and remove the undeployed valve from the abdominal aorta bifurcation.The delivery system balloon and valve were removed from the rest of the delivery system as a part of the surgical removal of the devices.Intima of the iliacs and aorta were damaged when the surgical exposure was made.The devices were removed.Patient was stable after aorta bifemoral repair with a vascular graft.The case was aborted.Imagery of the event was provided, and it was observed that the valve frame was damaged.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: corrected h6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.The valve 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 by the site and revealed the following: patient's left access vessel had presence of tortuosity.Multiple struts bent outwardly at the outflow side.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The instructions for use/training manuals were reviewed for guidance/instruction involving the valve usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 valve frame damage was confirmed based on imagery provided.Per imagery review, the outflow struts were bent outwardly due to the withdrawal of delivery system with crimped valve.As such, available information suggests that procedural factors (crimped valve withdrawal) 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 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: 18763530
• MDR Text Key: 336055244
• Report Number: 2015691-2024-01234
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 97 KG