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

Model Number 9750CM26A

Device Problem Material Rupture (1546)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences affiliate, regarding a 26mm sapien 3 ultra resilia valve in the aortic position.During valve deployment the 26mm commander delivery system balloon ruptured after 1-2 seconds of fill deployment.The commander balloon was removed from the patient without incident or complication from the esheath.After a replay of the fluoroscopy imaging during deployment, the implanting physicians surmised that calcium at the level of the stj most likely initiated balloon rupture as evidence of rupture as the precise point at the shoulder of the balloon made contact with the calcium stj lesion.After imaging review, the implanting physicians determined the valve to be fully deployed.Post-assessment of the deployed valve showed no pv leak and a mean gradient of 4 mmhg via tte.Implanting physicians concluded that post-dilation of the deployed valve was unnecessary, given the fluoroscopic and post-deployment clinical assessments.

Manufacturer Narrative

Investigation is underway.H3 other text : not returned.

Manufacturer Narrative

The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.The returned delivery system was visually evaluated, and the following was observed: balloon is burst longitudinally.Due to the condition of the returned device (e.G., balloon burst), no functional testing was able to be performed.Dimensional testing was performed.The inflation balloon single wall thickness was measured along the edges of the burst location and all measurements met specification.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported event was confirmed based on the returned product evaluation.Available information suggests patient factors (calcification) likely contributed to the event as the event description stated, calcium at the level of the stj most likely initiated balloon rupture as evidence of rupture as the precise point at the shoulder of the balloon made contact with the calcium stj lesion.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 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.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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 ; 9492506384
• MDR Report Key: 18361089
• MDR Text Key: 331190558
• Report Number: 2015691-2023-18564
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250618(10)65143607
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 65143607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female