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

Model Number 9610TF26U

Device Problem Material Rupture (1546)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards affiliate in (b)(6) , regarding a patient who underwent an implant of a 26mm sapien 3 ultra valve, in a pre existing edwards lifesciences mitral ring, by transfemoral approach, during the valve in ring procedure, the commander delivery system balloon burst at the last part of the deployment.There were no other procedural complications and patient was reported as fine.

Manufacturer Narrative

The 26mm commander delivery system was returned with stylet inserted.Loader cap was attached on the flex shaft.The ds was returned partially unlocked with no fine adjust and half flex used.The returned device was evaluated, and the following was observed: balloon burst longitudinally starting at approximately 2.5cm from the nose tip and ~ 4.5cm in length.No missing balloon material.Dimensional inspection was performed and single wall thickness of the balloon along the edges of burst location was taken.All measurements taken of the balloon single wall thickness met the specification per drawing.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 was confirmed by visual inspection of the returned device.However, no manufacturing nonconformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.A detailed root cause analysis for similar returned balloon burst complaints has been summarized in technical summary.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.Per the information provided for the complaint, the balloon was deployed in the mitral position inside a pre-existing ring with mild 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.Review of available information suggests that the balloon burst was likely caused by patient factors (calcification).

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12104489
• MDR Text Key: 260351563
• Report Number: 2015691-2021-03906
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1