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

Model Number 9750TFX23

Device Problem Material Deformation (2976)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a valve in valve case of a 23mm sapien 3 ultra in a degenerated non-edwards tavi valve, in the aortic position by transfemoral approach.During the insertion into the esheath, the struts of the valve were observed to be bent outward in the upper part.This valve was discarded and a new one was implanted without problems and complications.As per images received, they suggested bent struts and esheath damage.The patient outcome was uneventful.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined for any abnormalities and the following was observed: valve stuck at proximal part of sheath shaft.Two (2) struts were bent outwards at the inflow side.The frame was crooked at outflow side.A review of edwards lifesciences risk management documentation was performed for this case.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 complaint of valve frame damage was confirmed through returned product evaluation and provided imagery.An existing edwards 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.Product risk assessment is also captured in technical summary, which applies to this complaint event.The risks outlined in the pra remain the same.The pra documents the difficulty advancing the delivery system through the sheath, resulting in difficulty or the inability to introduce delivery system/loader and advance through sheath, prolonging procedure, which did occur during this event.Trending analysis indicates complaint rates are within the control limit.As the complaint did not exceed the pra re-escalation threshold, no further action is required.The root causes identified in the technical summary were reviewed and the following were identified as applicable to this event: 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 follow-up with field clinical specialist, the degree of tortuosity in patient's access vessel was medium.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.As per follow-up with field clinical specialist, the degree of calcification in patient's access vessel was medium.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 device evaluation and per imagery review, two (2) struts were bent on the inflow side.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.Based on available information, investigation suggests that patient factors (calcification, tortuosit y) may have contributed to the reported event.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training on how to introduce and navigate catheter through anatomy.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Complaint histories fo r 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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: (b)(4).

• Brand Name: EDWARDS 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: 17808493
• MDR Text Key: 324149625
• Report Number: 2015691-2023-16136
• 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: 12/01/2023

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: 9750TFX23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2023
• 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 Age: 83 YR
• Patient Weight: 80 KG