MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs) during a transfemoral tavr procedure, the first 26 mm sapien 3 ultra valve was almost at full deployment when a premature ventricular contraction (pvc) broke through and caused the valve to embolize in the aortic.They used the commander delivery system (ds) to drag the valve to the ascending aorta, past the left subclavian artery.Then post dilated the valve with a 30 zmed balloon to stabilize it in place.A new 26 mm sapien 3 ultra valve was successfully deployed with +2 cc added to the nominal volume (total 25cc) in the native aortic annulus.Post deployment, it was decided to inflate the 2nd 26mm commander ds balloon to attempt one more time to drag the first valve into the descending aorta.However, the commander delivery system balloon burst when inflated with the additional volume (25cc).As the valve appeared to be in stable position in the ascending aorta, it was decided to conclude the case.It was then attempted to remove the ds, but there was difficulty withdrawing the ruptured balloon into the esheath+.The distal portion of the balloon material was getting stuck at tip of the esheath+ and they were unable to get it completely into the sheath and pulled the devices out as a unit.The surgeon did a small nick at the groin (just in the skin, it was not a cutdown) and clamped the nose cone to help with the removal.The delivery system was removed successfully and intact (the nosecone was still attached to the catheter).The patient was stable post procedure.Per the fcs, the perceived cause of the 1st valve embolization was the pvc.The embolized valve position was canted due to being implanted in the ascending aorta curvature.It is possible that this, along with the additional volume, contributed to the ds balloon burst.There was no allegation that the events were due to an edwards device deficiency.The devices will not be returned for evaluation.This report is for the balloon burst with subsequent withdrawal difficulties.

Manufacturer Narrative

This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2023-10948.The investigation is ongoing.The delivery system was not returned for evaluation.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following section of this report has been updated: b4, g3, g6, h2, and h6.A device history review (dhr) and lot history did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.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 balloon burst and difficulty or inability to withdraw system through sheath were unable to be confirmed as neither the complaint device nor applicable imagery was provided.Due to unavailability of the complaint device, engineering was unable to perform visual inspection functional testing, or dimensional analysis.Imagery was provided from the site and revealed the following: 3mensio report was provided by the site, revealing the no relevant calcification visible in ascending aorta.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.The complaint description states, ''post deployment, it was decided to inflate the 2nd 26mm commander ds balloon to attempt one more time to drag the first valve into the descending aorta.However, the commander delivery system balloon burst when inflated with the additional volume (25cc).As the valve appeared to be in stable position in the ascending aorta, it was decided to conclude the case.It was then attempted to remove the ds, but there was difficulty withdrawing the ruptured balloon into the esheath+.The balloon had a circumferential tear, and the distal portion of the balloon material was getting stuck at tip of the esheath+.'' additionally reported, ''the embolized valve position was canted due to being implanted in the ascending aorta curvature.It is possible that this, along with the additional volume, contributed to the ds balloon burst.'' while the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, a pre-existing valve or over-inflation of the balloon can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.In this case, the embolized valve was pulled into the descending aorta and deployed canted in a curvature section with an additional 2cc.If the balloon was overinflated, in addition with the canted pre-existing thv, the balloon pressures may be high enough to cause the balloon to burst.Furthermore, as the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.Review of available information suggests that procedural factors (canted valve, over-inflation) contributed to the balloon burst while procedural factors (withdrawal of burst balloon) contributed to the withdrawal difficulty.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC 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: 16400876
• MDR Text Key: 309869394
• Report Number: 2015691-2023-10949
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)241020(10)64679094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64679094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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: 81 YR
• Patient Sex: Male