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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

Patient Problem Cusp Tear (2656)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a transfemoral transcatheter aortic valve replacement (tavr) with a 26 mm sapien 3, after valve deployment there was mild aortic insufficiency.The physician re-wired and ballooned the area causing damage to the tavr valve and to the mitral leaflet.The patient was emergently opened for repair.The patient is stable post procedure.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.In addition, no applicable imagery was provided for review.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints relating to frame damaged during use.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.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, therefore a manufacturing mitigation review was not performed.The frame damage reported in this event is likely a consequence of an incorrect wire placement for a non-ew bav device.In this case, the wire was not inserted through the valve, but through the side of the valve.As the bav was inflated, the balloon compressed the frame and aorta wall causing damage to the valve and to the mitral leaflet.Edwards risk management does not conduct risk assessments for events associated with non-ew devices.As such, the review of the risk management file is complete, and no further action is required at this time.The complaint for frame damage was unable to be confirmed due to no device/relevant imagery provided for evaluation.However, review of the dhr, and lot history provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials also revealed no deficiencies.As reported, ''during tf tavr with a 26mm s3, after valve deployment there was mild ai, the physician re wired what he thought was through the tavr valve, there was paravalvular and ballooned the area causing damage to the tavr valve and to the mitral leaflet.The was emergently opened for repair''.In this case, the guidewire was incorrectly placed prior to post-dilation.The wire was not inserted through the valve, but through the side of the valve, and this resulted in incorrect placement of the device.As the bav was inflated, the balloon compressed the frame and aorta wall causing damage to the valve and to the mitral leaflet.As such, available information suggests that procedural factors (user error -incorrect placement of wire) may have contributed to the complaint event.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation and corrective/preventative actions (capa) are not required.

• 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: 12291358
• MDR Text Key: 265594948
• Report Number: 2015691-2021-04549
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230422
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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 Expiration Date: 04/22/2023
• Device Model Number: 9750TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention