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

Model Number 9610TF23U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our edwards lifesciences affiliate in italy, regarding a 23mm sapien 3 ultra transcatheter heart valve implant implanted as a valve in valve procedure within a 23mm magna valve using transaxilliary approach during the procedure, when keeping the commander delivery system balloon inflated and waiting 5 seconds before deflating, blood was seen inside the inflation device and it was realized that the balloon perforated.It was thought that the ventricular part of the stent of the sapien valve may have caused the hole in the balloon, because the balloon in the ventricular part reached its nominal expansion of 23mm, however, the other part of the balloon and the surgical valve inside reached a diameter of 21mm.The ''flaring'' of the stent caused the perforation of the balloon.The perforation was so small that the behavior of the balloon even during deflation was standard.The implant was completed successfully and without consequences for the patient.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.The complaint for balloon leak was confirmed based on evaluation of the provided imagery.No manufacturing non-conformances were identified during the evaluation.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.The device was not returned for evaluation.As device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported ''a valve in valve procedure within a 23mm magna valve using transaxilliary approach.During procedure, when keeping the commander delivery system balloon inflated and waiting 5 seconds before deflating, blood was seen inside the inflation device and it was realized that the balloon perforated.It was thought that the ventricular part of the stent of the sapien valve may have caused the hole in the balloon, because the balloon in the ventricular part reached its nominal expansion of 23mm, however, the other part of the balloon and the surgical valve inside reached a diameter of 21mm.'' during manufacturing, balloons are 100% visually inspected at several different steps and devices are 100% leak tested.Therefore, it is unlikely that the delivery system left the manufacturing site with balloon damage.Additionally, there was no note of abnormalities or leakage on the delivery system during device preparation and de-airing, suggesting that there was no issue with the device when removed from packaging.Balloon leak may result from damage to the balloon material sustained through a combination of patient and/or procedural factors.The structural integrity of the balloon may be compromised via improper device preparation (crimping) or improper valve alignment techniques (excessive manipulation within tortuous/calcification anatomy).It may also be possible for the balloon to become damaged during delivery system advancement through sheath/vasculature via unfavored interactions between the balloon and the crimped thv (typically promoted by calcified, tortuous, and/or vessel-restricted anatomy via non-coaxial advancement angles) or interaction with pre-stent during placement in target site.In this case, the patient had a surgical stenotic 23mm magna valve.As per training manual viv ''diameters may be smaller than the manufacturer's internal diameter and labeled valve size, due to various mechanisms of bioprosthetic valve failure (i.E.Calcification, pannus)'' in this specific case, if the surgical valve's diameter was less than 23mm, inflating the balloon with the nominal volume (23mm) could lead to excessive inflation at the distal part.This interaction between an overinflated balloon and the valve frame could potentially cause a pinhole defect in the balloon.As such, available information suggests that patient (pre-existing stenotic surgical valve) and procedural factors (valve frame interaction with balloon) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective nor preventative actions are 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 ; 9492506385
• MDR Report Key: 18970728
• MDR Text Key: 338614829
• Report Number: 2015691-2024-02285
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208061
• UDI-Public: (01)00690103208061(17)250807(11)230808
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Lot Number: 65240528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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 Age: 65 YR