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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problem Burst Container or Vessel (1074)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.H3 other text : discarded.

Event Description

Edwards received notification from our affiliate in (b)(4).As reported, this was a valve-in-valve case of a 26mm sapien 3 valve implant in a 27mm surgical valve in mitral position by transeptal approach.At the end of the valve deployment the balloon of the commander delivery system burst longitudinally.Despite the balloon burst, the sapien 3 valve was successfully implanted.When retrieving the commander delivery system through the esheath, no issue was found.The commander delivery system was discarded.The patient did not experience any consequences from the event.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.A procedural video was provided, and the following was observed: the balloon burst during balloon inflation at full the end of the thv deployment.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.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 complaint balloon burst was confirmed as per provided procedural video to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, no manufacturing non-conformance was identified during the evaluation.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 follow up provided, ''the valve has developed a degree of calcification''.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.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.A review of available information suggests that patient factors (calcification) contributed to the balloon burst.Since no edwards defect was identified, no corrective or preventative action is required.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: PROSTHESIS, MITRAL VALVE, 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: 15705225
• MDR Text Key: 305884108
• Report Number: 2015691-2022-08933
• Device Sequence Number: 1
• Product Code: NPU
• 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: Foreign,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: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: 64438761
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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