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

Model Number 9750CM29A

Device Problems Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During a tavr procedure using a 29mm sapien 3 resilia valve via transfemoral approach, the balloon ruptured on inflation during deployment.The team pulled the ruptured balloon into the sheath.A decision was made to remove both the sheath and delivery as a unit.Upon removal, resistance was evident at the access site.The team could not remove the sheath and delivery system.At this point, the team wired from contralateral access site and used a 12.0mm balloon to occlude flow.A vascular surgeon proceeded with a cut down to remove the balloon and sheath.The common femoral artery was patched, and the patient is stable.The valve was deployed and fully functioning.The device will be returned for examination.

Manufacturer Narrative

The events reported are 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 29mm commander delivery system (ds) was returned for examination and confirmed the reported events.A visual examination found that the balloon burst radially with no missing balloon pieces observed, the distal portion of the distal balloon wing material was stretched, and the burst inflation balloon was caught at the distal end of the sheath.Dimensional testing indicated that all measurements taken of the balloon's single wall thickness met specifications.3mensio imagery provided showed that there was calcification present in the landing zone and that the patient had tortuous and calcified iliac vessels.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 complaint of a balloon burst was confirmed based on an evaluation of the returned device.Available information suggests that patient factors (calcification) likely contributed to the event.Per the event description and as observed in the provided imagery, the patient had a "moderate/severe" degree of calcification 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 the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via the following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.The complaint of withdrawal difficulties was confirmed based on the evaluation of the returned device.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the event.As the balloon burst, the altered balloon profile could have made it more susceptible to catching on the distal end of the sheath tip, which would have then led to the experienced retrieval difficulty.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: 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: 18089042
• MDR Text Key: 327586136
• Report Number: 2015691-2023-17315
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)250605(10)65116964
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Lot Number: 65116964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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 Age: 89 YR
• Patient Sex: Male