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

Model Number 9600TFX29A

Device Problems Migration or Expulsion of Device (1395); Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tmvr procedure with a 29mm sapien 3 valve in an incomplete non-edwards future band, the valve was deployed in the ring post lampoon with 5cc of additional volume in the balloon.Post valve deployment, severe paravalvular leak (pvl) was noted due to the shape of the incomplete ring.On tee, there was also question of one sapien 3 valve leaflets not opening properly, due to uneven expansion within the incomplete ring eyelets possibly impacting coaptation.The patient underwent a valve in valve (vinv) procedure with a 29mm sapien 3 valve with an additional 5 cc's of volume.Post implant, both valves embolized into the left atrium due to inadequate anchoring from the incomplete mitral band.Another 29mm sapien 3 valve was then attempted to be implanted in the mitral band.However, the patient had severe pvl.The team then decided to tack the two valves to the atrial wall with a wire/snare and externalized the venous wires.The plan is for the patient to have open heart surgery to explant of the valve with possible surgical mitral valve repair/replacement with a different surgeon the following day.The patient was in stable condition.

Manufacturer Narrative

Correction to b5 and h6 due to additional information received.

Event Description

It was initially reported by the field clinical specialist (fcs), that during a transfemoral tmvr procedure with a 29mm sapien 3 valve in an incomplete non-edwards future band, the valve was deployed in the ring post lampoon with 5cc of additional volume in the balloon.Post valve deployment, severe paravalvular leak (pvl) was noted due to the shape of the incomplete ring.On tee, there was also question of one sapien 3 valve leaflets not opening properly, due to uneven expansion within the incomplete ring eyelets possibly impacting coaptation.The patient underwent a valve in valve (vinv) procedure with a 29mm sapien 3 valve with an additional 5 cc's of volume.Post implant, both valves embolized into the left atrium due to inadequate anchoring from the incomplete mitral band.Another 29mm sapien 3 valve was then attempted to be implanted in the mitral band.However, the patient had severe pvl.The team then decided to tack the two valves to the atrial wall with a wire/snare and externalized the venous wires.The plan is for the patient to have open heart surgery to explant of the valve with possible surgical mitral valve repair/replacement with a different surgeon the following day.The patient was in stable condition.Upon follow up information received, the valves were explanted approximately 3 days later.

Manufacturer Narrative

Correction to h6 based on additional information.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 complaints for improper leaflet coaptation, deployed valve exhibits paravalvular leak and thv embolized into atrium were unable to be confirmed due to unavailability of relevant imagery and/or medical record.Per the event details, a 29mm sapien 3 thv was deployed inside of an 'incomplete non-edwards ring.' post valve deployment, severe paravalvular leak (pvl) was noted due to the incomplete ring.Additionally, one the imaged leaflets was in question in terms of not opening properly, due to 'uneven expansion within the incomplete ring eyelets possibly impacting coaptation.' after a viv was performed with a 29mm s3 thv and additional 5cc's of volume, both valves embolized into the left atrium due to inadequate anchoring from the incomplete mitral band.' per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.In this case, the thv was deployed with extra volume (+5cc) within an 'incomplete' mitral ring.This likely caused increased gap within the commissural side of the ring (incomplete side where the two termini meet) due to excess stretching/over-expansion.The resulting gap could promote interspatial voids between the thv at the ring commissural side, leading to pvl due to compromised sealing characteristics.Deploying the thv inside the incomplete mitral ring could have also yielded asymmetric expansion of the valve itself resulting in over expanded and under expanded thv sides in contact with the commissural and continuous portions of the ring, respectively.The under expanded thv side would also be prone to the formation of pvl channels between the thv skirt and the ring.As such, available information suggests that patient factors (incomplete shape of pre-existing ring) may have contributed to the complaint event.In this case, the presence of an 'incomplete' mitral ring could have caused the thv to expand unevenly during deployment with 5 extra cc's.The incomplete ring side would be able to open up/stretch out more while accommodating excess inflation volume versus the continuous ring side.This likely caused the thv to expand unevenly, resulting in the thv over-expansion at the commissural ring interface but under expansion at the continuous ring interface.The unevenly expanded thv could subsequently interfere with proper leaflet coaptation (e.G.Preventing the leaflet from opening properly due to asymmetric valve profile).As such, available information suggests that patient factors (incomplete shape of pre-existing ring) may have contributed to the complaint event.Per the instructions for use (ifu), valve embolization is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, the incomplete ring shape (and the associated excess gap upon thv inflation) likely prevented the thv from being properly secured against target site.This could have led to weakened attachment forces, further attenuated by implantation of the second valve, causing both the valves to detach and embolize into atrium.As such, available information suggests that patient factors (incomplete shape of pre existing ring) may have contributed to the complaint event.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 or preventative actions are required.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: MITRAL 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: 16393278
• MDR Text Key: 309735170
• Report Number: 2015691-2023-10889
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)251009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 140031
• 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,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue 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: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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