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

Model Number 9750CM20A

Device Problem Material Rupture (1546)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The device was discarded.

Event Description

During a tavr procedure using a 20mm sapien 3 ultra valve via transfemoral approach, during valve alignment the balloon was placed in the valve, and the distal marker was more than 3mm in the valve.Due to the placement of valve alignment, a decision was made to prepare a new valve.The operator was able to pull the valve back into esheath+.The original esheath+, delivery system, and valve were removed all together.The esheath+ had a slight tear, from placing the valve back into the esheath.A new 14f esheath+, delivery system, and 20mm valve were prepared per the ifu.As the valve was deployed the balloon ruptured at the very end of deployment, all volume was given.Echo showed no pvl or central leak.The operator was able to remove the delivery system with no further complications.Upon inspection of the delivery system balloon, vertical balloon rupture was present.No further complications were noted.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.The commander delivery system (ds) was not returned for evaluation without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.Imagery was reviewed and the following observations were observed: the balloon bust longitudinal and there was calcification in the valve landing zone.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.This event reports a balloon burst during thv deployment that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.The complaint for balloon burst was confirmed through the provided imagery.However, no manufacturing non-conformance was identified during the evaluation.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 per 3mensio, calcification was present in the landing zone.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 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 +2cc 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.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.In this case, a review of available information suggests that patient factors (calcification) and procedural factors (over-inflation) contributed to the balloon burst.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.No corrective or preventative actions are required.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROTHESIS, 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: 16230620
• MDR Text Key: 308143865
• Report Number: 2015691-2023-10321
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)230429(10)63778978
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: 9750CM20A
• Device Catalogue Number: 9750CM20A
• Device Lot Number: 63778978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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: 76 YR
• Patient Sex: Female