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

Model Number 9750CM26A

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a tf viv tmvr procedure for a 26mm sapien 3 ultra valve in a 27mm surgical valve, wire was lost during the first valve alignment step.Recrossing the mitral valve was attempted, but unsuccessful.Upon removal of the sheath and delivery system as a unit, the esheath and delivery system with the valve 'separated' from one another.There was a common femoral vein injury (cfv); bleeding was not able to be controlled and a cutdown repair of the cfv was performed.There was no evidence of stent frame or esheath damage reported.After the vessel repair, a second valve, delivery system, and 14f esheath was opened and successful implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for product device investigation result and correction of h6 for type of investigation, investigation findings and investigation conclusions has been updated.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint.All inspections are conducted on 100% of the units.Dhr review was unable to be performed as the device lot number was not provided.Lot history review was unable to be performed as the device lot number was not provided.The instruction for use (ifu) were reviewed for the commander delivery system, s3u commander preparation training manual, s3u commander procedural training manual, supplement to edwards sapien 3/sapien 3 ultra with the commander delivery valve-in-valve patient screening and procedural training manual (mitral position).No ifu/training deficiencies were identified.The procedural training manual provides guidance on thv retrieval back into sheath tip.Thv can be retrieved through sheath only before thv deployment (still crimped).Ensure the thv is centered on the flex tip.Ensure delivery system is locked.Verify the flex catheter is completely unflexed.Retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.Ensure the edwards logo on the sheath handle is facing upward.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.Crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.Do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.Retrievability is based on preclinical testing.Additionally, an assessment of the following is recommended prior to mitral valve-in-valve implantation with sapien 3 ultra.A bioprosthesis failure mode (regurgitation/stenosis), significant pre-existing paravalvular leakage, degree of leaflets calcification, presence of intracardiacmass, thrombus, or vegetation on leaflets, right atrium, left atrium or left ventricle (risk of embolization), rv function and pulmonary hypertension (increased procedural risk), lv function and apical aneurysm to determine appropriateness for transapical access, suitability for transseptal(ts) approach: inter-atrial septum anatomy; presence of devices precluding ts access (septal occluder; cavalfilter), risk of lvot obstruction and sizing confirmation.A review of the risk management documentation was performed, and 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.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The risk of being unable to retrieve system with crimped/partially inflated thv and associated harms has been reduced as low as possible through design and manufacturing processes.Edwards has provided guidelines and instructions to the physicians in the ifu and training materials/refresher training on how to withdraw the valve through the sheath.Users are informed of the residual risks associated with use of the delivery system and sheath through the potential adverse events section in the instructions for use (ifu) and/or device training materials.The benefits of the system outweigh the risks associated with difficulty withdrawing the delivery system with a crimped thv.The complaints was unable to be confirmed.Due to the unavailability of returned device and/or applicable imagery, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing nonconformance was unable to be determined.A review of the ifu and training manuals revealed no deficiencies.Per the complaint description, "upon removal of the sheath and delivery system as a unit, the esheath and delivery system with the valve separated.It was suspected that the stent portion got stuck in the vessel tissue".It is possible that the patients vasculature was tortuous and calcified.If so, the potential interaction of the thv's stent and patient anatomy may have lead to the reported event of valve moving off of inflation balloon.However, due to the lack of device and patient imagery, a definitive root cause is unable to be determined at this time.In this case, available information suggests patient factors (calcification) may have contributed to the reported event.However, a definitive root cause was unable to be determined.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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
• MDR Report Key: 11777692
• MDR Text Key: 249092664
• Report Number: 2015691-2021-02804
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2021

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: 9750CM26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention