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

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  Injury  

Event Description

As reported by the edwards clinical safety team for the alterra post approval study, during a pulmonic valve replacement procedure, the a lterra prestent was placed in the patient.The 29mm sapien 3 valve was introduced in the patient and slow, steady inflation was performed with adjustments made during inflation.The sapien 3 valve was deployed at a canted angle, too proximal, within the waist of the alterra (pa side 40%/rv side 60% on medial/inferior side).Angiogram showed mild s3 pvl.The decision was made to place a second sapien 3 valve, which was prepped on a new delivery system.The delivery system was inserted and advanced into the alterra/sapien 3 with a more distal position.The final position was slightly more distal than the first valve.Ice confirmed no pvl, no pal, and no central leak.The patient remained stable throughout procedure and was transferred in stable condition.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Corrected h.6 type of investigation, investigation findings, and investigation conclusions based on investigation closure.The valve was not returned for evaluation.During manufacturing of the sapien 3 transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The ifu and procedural training manual were reviewed.Device dysfunction (regurgitation and/or stenosis) and device migration or malposition are listed as potential risks associated with the use of the valve, delivery system, and/or accessories.While positioning the thv within alterra, place the sapien 3 completely within the waist of the alterra prestent.Target final implant position of the sapien 3 valve in the middle of the alterra waist.Utilize multiple fluoroscopic views.Positioning considerations include movement during deployment, pulmonary branch location in relationship to balloon catheter, coaxiality of crimped valve within the alterra, and valve fixation during deployment.Once the valve is positioned at the desired landing zone uncover the valve.Verify the thv position under fluoroscopy.During thv deployment, check to ensure the valve capsule is fully retracted prior to deployment.Confirm placement of positioning marker within intended landing zone.Begin initial deployment with a slow controlled inflation.Reposition thv as necessary.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon and withdraw.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.If considered, reposition only at the very early stage of deployment.Always maintain control of the plunger of inflation device when releasing it.Assess the valve and prestent post deployment using fluoroscopy.No ifu/training deficiencies were identified.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.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.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defects were identified, no corrective or preventative actions are required.The malpositioned valve and pvl were confirmed based on the provided medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals revealed no deficiencies.As reported, ''the sapien 3 valve was deployed at a canted angle, too proximal, within the waist of the alterra (pa side 40%/rv side 60% on medial/inferior side).Angiogram showed mild s3 pvl''.In this case, the valve may not have been positioned coaxially within the alterra prior deployment, so it led to ''canted angle'' deployment or malpositioned thv.As such, available information suggests that procedural factors (valve positioning and deployment technique) may have contributed to the complaint event.Due to the malposition of deployed valve, the deployed valve cannot properly seal against the target site (alterra pre-stent), resulting in paravalvular leak as reported.As such, available information suggests that procedural factors (thv malpositioned) may have contributed to the complaint event.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY 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: 16162660
• MDR Text Key: 307466499
• Report Number: 2015691-2023-10184
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: 19 YR
• Patient Sex: Female