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

Model Number 9600LDS29A

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Difficult to Remove (1528)

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

Event Date 11/16/2022

Event Type  Injury  

Event Description

Edwards received notification from a thv territory manager that during a transfemoral tavr, the first valve would not properly align in the descending aorta.The fine adjustment wheel was not moving the valve.Then the large wheel was not articulating the catheter.It was repositioned and it worked.The valve was still not perfectly aligned but it was felt that it was good enough.When it was placed in the annulus the valve would not inflate.Blood was noted to be in the syringe.No damage was overserved on the balloon.The sheath was not noted to be damaged.The first sapien 3 26mm valve and the delivery system were successfully removed.A second valve and delivery system were prepped and the same esheath from the 1st attempt was used.The valve was implanted in the native annulus but the balloon ruptured at full inflation.The patient had moderate to heavy calcification.The balloon would not go into the 16fr esheath.It was attempted to remove sheath and balloon together but the balloon kept catching on the calcium in the common iliac artery.Multiple steps were taken to remove, to include pushing forward and rotating, and snaring from the contralateral side.The decision was made to do a retroperitoneal cutdown to access the iliac artery prophylactically so if any rupture happened it could be controlled.The delivery system was forcefully pulled into the sheath.The balloon sheared off in esheath.No intervention was needed on the iliac artery.The patient's abdomen was closed and sheath removed.The esheath had to be cut open on the back table afterwards to make sure the balloon material was not in the patient.Prior to the esheath being cut open, there was no damage observed.It was confirmed that there were no missing balloon pieces in the patient and all balloon material accounted for.The patient remained stable during and after the procedure.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-09743.

Manufacturer Narrative

Supplemental report submitted to include additional information received.Corrected h6 component codes.Per pre-deco evaluation, the 29 mm commander delivery system was returned with proximal portion of the balloon shaft cut and not returned.The balloon was burst radially and longitudinally at proximal shoulder and distal tip separated distal part of balloon inverted over nose tip.There was a cut on the nose tip.No material appeared to be missing.The spring was stretched and adhesive present on guidewire lumen.The balloon was torn by engineering.The nose tip was cut, likely by scissors during removal from the sheath by the field.The investigation is in progress.A supplemental report will be submitted.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected and the following was observed: commander balloon burst radially and longitudinally at proximal shoulder and distal tip separated.Distal part of balloon inverted over nose tip, cut on nose tip.No material appeared to be missing.The spring was stretched and adhesive present on guidewire lumen.The balloon was torn by engineering.The nose tip was cut, likely by scissors during removal from the sheath by the field.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 of balloon burst, difficulty or inability to withdraw system through sheath, and distal tip separation during use were confirmed by visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As reported, ''the patient had moderate to heavy calcification''.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.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.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.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.

• Brand Name: 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: 15941830
• MDR Text Key: 305084914
• Report Number: 2015691-2022-09744
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240131(10)64215920
• 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,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 64215920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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 Sex: Male