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 03/12/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by a field clinical specialist, during implant of a 26 mm sapien 3 ultra valve in the mitral position via transeptal approach into a preexisting non edwards surgical valve the wire position was lost just prior to valve positioning.The commander system with valve was being withdrawn and the sapien valve came off of the system and lodged into the femoral vein.The valve became dislodged while removing system from the femoral vein.There was no withdrawal difficulty.A cutdown was required to remove the valve from the vessel.After the vessel was controlled the procedure continued.A new commander and sapien ultra 26mm were deployed successfully in the correct mitral valve in valve position.There was no damage to any of the devices.Procedure was completed and patient left the cath lab and taken to icu for recovery.Per medical opinion, the event was likely due to the valve not being drawn into the tip of the esheath far enough to partially cover the frame, prior to removal from femoral vein.The exposed valve frame became snared in the wall of the vein during removal.Likely the physician was holding pressure on the vein to prevent bleed back which also added to the exposed valve becoming caught in the wall of the vein.

Manufacturer Narrative

The product was not returned for evaluation.Procedural imagery provided by the site showed the patient had significant tortuosity around the landing zone with no calcification.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The commander delivery system complaint history has been reviewed and no confirmed manufacturing non-conformance were identified.The occurrence rate did not exceed the monthly control limits for the trend category.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.Regarding delivery system insertion through sheath: orient the delivery system with the flush port pointing away and the edwards logo facing up, ensure delivery system is locked in default position.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion.Push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.If push force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm.In expectation of high friction, use short movements.If working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.It is to be noted, if push force is too high or valve is still stuck, remove valve and sheath together as a single unit and replace.During the manufacturing process, the device was visually inspected and tested several times.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint event.A review of edwards lifesciences risk management documentation was performed for this case.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint for delivery system valve dislodged from balloon was unable to be confirmed due to the unavailability of the device and or applicable imagery.Therefore, a manufacturing non conformance was unable to be determined.A review of the ifu and training manuals revealed no deficiencies.As reported, the commander system with valve was being withdrawn and the sapien valve came off of the system and lodged into the femoral vein.The valve became dislodged while removing system from the femoral vein.When retrieving a crimped valve, the procedural training manual states, withdraw the delivery system and sheath as a single unit completed from the arteriotomy while maintaining guidewire position.Case notes further detailed, i reminded them to pull the valve into the sheath as much as possible prior to removal and they thought it had been drawn into the sheath far enough.I also believe the person who was holding pressure on the groin was pressing too hard which caused the valve to get snagged in the vessel wall during the removal.From the information gathered.The valve was not fully house within the sheath shaft prior to the sheath and delivery systems removal.The improper withdrawal techniques used by the physician (valve held against vessel wall during removal) potentially lead to the reported events of thv dislodging off of inflation balloon.Available information suggests procedural factors (improper withdrawal techniques) contributed to the reported event.However, a definite root cause is unable to be determined.Due to the unavailability of the device, it cannot be determined if a manufacturing non-conformance contributed to the reported events.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.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation, no product risk assessment, corrective or preventative actions are 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: 11611233
• MDR Text Key: 251781573
• Report Number: 2015691-2021-02250
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR