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

Model Number 9750TFX23A

Device Problem Material Deformation (2976)

Patient Problem Rupture (2208)

Event Date 08/08/2023

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve, the valve was inserted into the esheath+ and there was some pressure noted.The operator gave 2cc of propofol in the esheath+, and the valve went across the narrowed area.The valve advanced through the esheath+, but once it exited the esheath+, the inflow struts were bent backwards.The operator tried to pull the system back as one.The fcs exited the room to prep a new esheath+.However, as the fcs came back, cpr was initiated, and the patient had a rupture to the left common iliac.The physician called for an occlusion balloon, but there was none in the facility.A balloon was attempted from the contralateral side to try and occlude the iliac.At this point the patient had passed away and the physician called time of death.

Manufacturer Narrative

The complaint for frame damage was confirmed through provided imagery.An existing technical summary written by edwards lifesciences captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in technical summary were reviewed and the following were identified as applicable to this event: undersized vessels (e.G.Due to anatomical variation, pre existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in challenging pathway during delivery system advancement leading to resistance.Per imaging evaluation, patient's access vessels had undersized vessels.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub optimal angles during delivery system insertion that may lead to resistance.Per imaging evaluation, patient's access vessels had calcification.Excessive device manipulation/ high push force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve inflow side.Per the description, when the 'valve was inserted into the esheath+ and there was some pressure noted'.Additionally, propofol was used in order to aid in the insertion showing that there was very high pressure and required additional accessories to attempt full insertion.The presence of the above factors can create challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath resulted in frame damage.The technical summary also outlines the extensive manufacturing mitigations in'place to detect a defect or nonconformance associated with this issue.There are several 100% in process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.As such, available information suggests that patient factors (calcification, undersized vessels) and/or procedural factors (excessive device manipulation, high push force) may have contributed to the reported 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: 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: 17672793
• MDR Text Key: 322535894
• Report Number: 2015691-2023-15671
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)260320
• 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: 10/13/2023

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: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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): Death; Required Intervention