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 09/20/2023

Event Type  Death  

Manufacturer Narrative

This is one of three reports being submitted for this case.Please reference manufacturer report no.2015691-2023-16721 and 2015691-2023-16722.The investigation is ongoing.H3 other text: the valve was not returned for evaluation.

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 26mm sapien 3 ultra resilia valve, the 14f esheath plus went up with no troubles at all.The physician tried to advance the 26 mm commander delivery system and the valve with a great deal of resistance.It started to move a bit more proximal with a little backwards tension and removal of the sheath.They continued to try to advance with no luck, and showed that the valve was stuck and the delivery system was coiling up on itself and kinked.They tried to remove the entire delivery system and sheath together to maintain the valve in the sheath.However, upon sheath removal the valve stripped off the balloon and was lodged in the common femoral artery.They maintained wire position and tried many ways to pull the valve back lower to grab with kellys.There was no luck, the vascular surgeon scrubbed in.They inserted a coda balloon into the distal aorta to maintain blood pressure as the valve was carefully removed from the artery and the artery repaired with a 10 mm dacron graft.After repair a runoff was performed which showed a clot at the popliteal artery.The ic performed angiojet and was able to reestablish flow downstream.The case was aborted and no valve was implanted.The patient was stable and taken off the table.Per additional information received from the fcs the patient expired.Per the fcs, after removal it was noted the sheath was damaged and the valve struts were bent.The kink on the commander was within the first 20 cm.The valve never exited the tip of the sheath.There was no abnormalities noted with the sheath prior to use.The expansion tool was used and the fcs believes the loader was able to be fully inserted into the sheath/sheath housing.The sheath angle didn't appear to be steep but the scrub techs said it was more of a vertical stick.The delivery system was at the sheath housing and partially expandable portion when resistance was noted.Per engineering review of a photo provided there was multiple bent struts at outflow side and the valve frame was distorted/damaged at outflow side.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The complaint for valve frame damage and subsequent unspecified vascular injury was confirmed through provided imagery.As the device was not returned, engineering was unable to perform any visual examination, 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.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen during advancement, leading to resistance.As per provided imagery, patient's access vessels had presence of tortuosity.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.As per provided imagery, patient's access vessels had presence of calcification.A steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.As per description, ''the sheath angle didn't appear to be steep, but the scrub techs said it was more of a vertical stick''.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.As per description, ''the physician tried to advance the 26 mm commander delivery system and the valve with a great deal of resistance.'' and the delivery system ''started to move a bit more proximal with a little backwards tension and removal of the sheath''.Per additional information, the valve and the commander did not exit the sheath.It was also noted that no imagery was provided during delivery system insertion.Additional manipulation may have further damaged the frame at the outflow side as observed.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 mitigation 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, tortuosity) and/or procedural factors (excessive device manipulation, high push force, steep insertion angles) may have contributed to the reported 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 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: 17916531
• MDR Text Key: 325443092
• Report Number: 2015691-2023-16724
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260315(11)2303162110512461
• 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: 11/21/2023

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: 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: Not provided
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Patient Sex: Male