MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM WITH SAPIEN 3; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned for evaluation, no visual inspection, dimensional testing, or functional testing could be performed.No imagery was returned for review.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the relevant complaint code.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.In this case, the 26 mm sapien 3 ultra valve (s3u) was implanted at the pulmonic position.Currently, the sapien 3 ultra valve (s3u) with the commander delivery system is not indicated for surgical bioprosthetic pulmonic valve replacement or a rvot conduit in pulmonic position.As such, it is considered off-label use for sapien 3 ultra valve (s3u) with commander delivery system.The ifu and training manuals in this section are for tf (transfemoral) procedure in rvot conduit or surgical bioprosthetic in pulmonic position and was reviewed for relevant guidance for a sapien 3 valve (s3) implant using a commander delivery system.The following instructions were reviewed: ifu for commander delivery system, device preparation manual, and device training manual.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 balloon leak was unable to be confirmed as neither the complaint device nor applicable imagery 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.Per the complaint description, ''the valve was aligned inside the 22fr dryseal and tore the commander distal portion of balloon.'' the device prep manual instructs the operator perform valve alignment during device prep, outside the patient, prior to insertion into the sheath when using the gore dryseal sheath.Performing valve alignment in the sheath may result in high valve alignment forces and unseat the valve.If the valve is unseated during alignment, it can result in interaction between the valve and the crimp balloon, which may have punctured the balloon and resulted in the reported ''leak.'' likewise, the off-label use of the sapien 3 ultra (s3u) valve may have also contributed to the reported event as the commander delivery system is not indicated for use with the s3u valve in the pulmonic position.Available information suggests that procedural factors (valve alignment performed in sheath, off-label use) may have contributed to the complaint events.However, a definitive root cause was unable to be determined.Since no edwards defect was identified, no corrective or preventative actions are required.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 or preventative actions are required.

Event Description

As reported by field clinical specialist, the 26mm sapien 3 ultra valve was aligned inside the 22fr dryseal and tore the commander distal portion of balloon, during a valve in a non-edwards surgical valve in the pulmonic position.There is no indication of injury to the patient.A second system was used.The devices were discarded.The valve did not exit the sheath.The valve was aligned within the sheath, as it was the straightest portion of the vessel.There was no resistance when inserting the delivery system into the sheath.There was no separation.No photos are available.There was no injury to the patient.The devices were removed without intervention.There was no damage to the sheath or valve.

Manufacturer Narrative

The device is not available for return.Investigation is ongoing.Device discarded.

Event Description

As reported by field clinical specialist, the 26mm sapien 3 ultra valve was aligned inside the 22fr dryseal and tore the commander distal portion of balloon, during a valve in a non-edwards surgical valve in the pulmonic position.There is no indication of injury to the patient.A second system was used.The devices were discarded.The valve did not exit the sheath.The valve was aligned within the sheath, as it was the straightest portion of the vessel.There was no resistance when inserting the delivery system into the sheath.There was no separation.No photos are available.There was no injury to the patient.The devices were removed without intervention.There was no damage to the sheath or valve.Additional information indicated it was observed on fluoro because as they could not align the valve any further.They placed a 50cc syringe onto the balloon stopcock and blood was pulled back into syringe.It did not look like an ic bond break.

Manufacturer Narrative

Additional information indicated it was observed on fluoro because as they could not align the valve any further.They placed a 50cc syringe onto the balloon stopcock and blood was pulled back into syringe.It did not look like an ic bond break.

• Brand Name: COMMANDER DELIVERY SYSTEM WITH SAPIEN 3
• Type of Device: PULMONARY 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: 13667256
• MDR Text Key: 290442786
• Report Number: 2015691-2022-04249
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)230928(10)64009604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 9750CM26A
• Device Catalogue Number: N/A
• Device Lot Number: 64009604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: Male