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

Model Number 9610TF23U

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 10/24/2022

Event Type  malfunction  

Event Description

Edwards received notification from our affiliate in italy.As reported, this was a case of an implant of 23mm edwards sapien 3 ultra transcatheter heart valve, in the aortic position by transfemoral approach.An initial valvuloplasty was performed to the native valve successfully.At the end of the valve deployment, the balloon of the commander delivery system burst transversally to the catheter axis.The balloon rupture occurred close to the nosecone, just a few millimeters away.After an angiography, it was decided to try remove the commander delivery system through the esheath.After some initial resistance, the delivery system exited from the esheath.The esheath was removed and replaced.A valvuloplasty was performed with a new and different bav catheter.The outcome is good and the femoral access was not damaged.The separation happened on the back table.One of the operator was examining the balloon and tore off the piece.As per the pre-decontamination evaluation findings, a piece of balloon 4.5 cm in length corresponding to the central area of the balloon was returned but did not match with edges of the balloon remaining on delivery system.Potentially, there was missing balloon material.Per field clinical specialist, the separation happened on the back table.One of the operators was examining the balloon and tore off the piece.

Manufacturer Narrative

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.Review of returned device showed the following observations: the balloon burst was confirmed.A piece of balloon 4.5 cm in length corresponding to the central area of the inflation balloon was returned but did not match with the edges of the balloon material remaining on the delivery system.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 complaint of balloon burst, difficulty withdrawing the delivery system through sheath, and balloon components separated during use was 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.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.An existing edwards' 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.Case notes provided indicated that the degree of valve calcification was mild.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.Additionally, it was noted that an additional volume of 2ml was added to the balloon.The prescribed nominal inflation volume is provided in the ifu that was documented in the technical summary.It is possible the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.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 the available information suggests that patient factors (calcification) and procedural factors (over-inflation) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.No manufacturing non-conformance was identified during the evaluation.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.

Manufacturer Narrative

Supplemental report submitted to h10 conclusion per additional review.H10: the device was returned for evaluation and an engineering evaluation was performed.Review of returned device showed the following observations: the balloon burst was confirmed.A piece of balloon 4.5 cm in length corresponding to the central area of the inflation balloon was returned but did not match with the edges of the balloon material remaining on the delivery system.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 complaint of balloon burst, difficulty withdrawing the delivery system through sheath, and balloon components separated during use was 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.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.An existing edwards' 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.Case notes provided indicated that the degree of valve calcification was mild.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressures, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Additionally, it was noted that an additional volume of 2ml was added to the balloon.The prescribed nominal inflation volume is provided in the ifu that was documented in the technical summary.It is possible the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.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 the available information suggests that patient factors (calcification) and procedural factors (over-inflation) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.No manufacturing non-conformance was identified during the evaluation.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: 15827302
• MDR Text Key: 306447553
• Report Number: 2015691-2022-09357
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Catalogue Number: N/A
• Device Lot Number: 64555330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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 Age: 89 YR
• Patient Sex: Female