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

Model Number 9750CM23A

Device Problems Inflation Problem (1310); Material Deformation (2976)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : device will not be returned.

Event Description

During a tavr procedure using a 23mm sapien 3 ultra valve via transfemoral approach, the balloon was slightly misaligned by 1mm.The team decided to still deploy the valve, the balloon ruptured before the extra cc could be pushed in.The team was able to remove the balloon without issue and post-dilated dilated with a new 23mm delivery system +1cc.No patient injury was reported.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.The 23mm commander delivery system (ds) was not returned for examination.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The 3mensio imagery showed calcification present within the patient's aortic root.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint code.The following instructions for use (ifu) were reviewed: commander delivery system, device preparation training manual, and the procedural training manual.Based on this review, no ifu/training deficiencies were identified.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 reported event of balloon burst and valve not between alignment markers were unable to be confirmed as no device or relevant imagery showing the misaligned valve and balloon burst during deployment was provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were reported during device preparation or valve alignment.The complaint description states, "the team decided to still deploy the valve, the balloon ruptured before the extra cc could be pushed in".Additionally, per the 3mensio review, calcification was present within the patient's aortic root.The balloon burst could be potentially from multiple factors (i.E.Calcified annulus/leaflets, additional inflation volume, and previous implanted valve).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.

• 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: 18368915
• MDR Text Key: 331097321
• Report Number: 2015691-2023-18622
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)250416(10)65098683
• 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: 02/12/2024

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 Model Number: 9750CM23A
• Device Lot Number: 65098683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• 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 Sex: Female