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

Model Number 9750CM26A

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 08/25/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification from a sales rep that during a transfemoral tavr with a 26mm sapien 3 ultra valve, the balloon of the 26mm commander delivery system burst at the end of inflation.When attempting to remove the delivery system from the 14fr esheath+, the nose cone of the commander system could not be pulled into the sheath.The operator attempted to pull the sheath and delivery system out as a unit and nose cone caught at the arteriotomy.A surgical cutdown was needed to remove the system.The patient was stable post procedure.The 26mm s3u valve was noted to be performing as intended.Through follow up it was noted, the sheath tip was in the abdominal aorta when the delivery system was attempted to be removed and could not, the full sheath and delivery system were attempted to be removed together at the groin site softly, when resistance was met the team stopped to prevent an injury and performed a surgical cutdown to remove the devices.Upon inspection, there appeared to be missing balloon material.However, there were no missing balloon pieces found in the patient.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was evaluated, and the following was observed: the balloon burst confirmed.The balloon was received inverted over the nose tip.Inflation balloon fragment found in packaging.A j tear was observed on inflation balloon.The inflation balloon single wall thickness was measured along the edges of the burst location.All measurements taken of the balloon single wall thickness met the specification.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, balloon serperation, and withdrawal inability were confirmed upon visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.No visual abnormalities were observed on the returned sample.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.As per provided imagery there was presence of calcium at the sinotubular junction.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) contributed to the withdrawal difficulty and separation.No evidence of product non-conformances or labeling/ifu inadequacies were identified in 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: 15450293
• MDR Text Key: 300215753
• Report Number: 2015691-2022-07955
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240531(10)64398111
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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: N/A
• Device Lot Number: 64398111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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