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

Model Number 9755RSL29J

Device Problem Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-15985.The investigation is ongoing.H3 other text : valve remains implanted.

Event Description

During a tavr procedure using a 29mmsapienn 3 ultra resilia valve, strong resistance was felt during sheath insertion, especially around the partially expandable area of the esheath+.When the commander delivery system was inserted into the esheath+.The delivery system was not able to advance.After pushing with more force, the delivery system was able to advance, but the stent of the thv valve appeared to bend outward and protrude from the esheath+ on fluoroscopy, so the delivery system and esheath+ were removed together.As angiography showed a rupture of the external iliac artery (eia), a balloon was used to stop the bleeding, and a covered stent was placed.Since hemostasis was confirmed by angiography, a new esheath+ and delivery system were used, and the procedure was completed without any problems.The physician and ew clinical specialist believe that eia rupture was caused by the valve stent protruding from the esheath+.The patient had received blood transfusions before the eia rupture, but blood transfusion was performed by pumping after the eia rupture.The esheath+ was prepared as instructed in the training manual.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.The 29mm sapien 3 ultra resilia valve was returned for examination and the reported events were confirmed through evaluation of the returned device.A visual examination found that the frame was slightly distorted, two bent struts at the inflow side, and the leaflets were observed to be slightly wrinkled.Due to the nature of the complaint engineering could not perform functional testing or dimensional analysis.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.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with the delivery system and valve frame damage as a result of increased push force.Product risk assessment is also captured in the technical summary, which applies to this complaint event.The pra documents the difficulty advancing the delivery system through the sheath, resulting in system components interfering with access vasculature resulting in additional percutaneous intervention, which did occur during this event.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 reported, "there was mild tortuosity in the access vessel." 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 reported, "the access vessel calcification was moderate." excessive device manipulation/high push force can lead to the valve struts interacting with the sheath shaft resulting in strut damage at the valve inflow side.As reported in the event description, "after pushing with more force, the delivery system was able to advance, but the stent of the thv valve appeared to bend outward and protrude from the esheath+ on fluoroscopy." also, per imagery evaluation, two (2) struts were bent on the inflow side and exposed through the torn sheath.The presence of the above factors can create a 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 resulting in frame damage.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or non-conformance associated with this issue.There are several 100% in-process inspections (visual) performed in the 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, an 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.In this case, based on available information, investigation suggests that patient factors (calcification, tortuosity) 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.

• 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: 17762147
• MDR Text Key: 323577501
• Report Number: 2015691-2023-16001
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217346
• UDI-Public: (01)00690103217346(17)251027
• 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: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: 9755RSL29J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/16/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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: 84 YR
• Patient Sex: Male