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

Model Number 9600LDS29A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a transfemoral transcatheter pulmonic valve replacement with a 29mm sapien 3 valve in a previously implanted edwards surgical valve, the delivery system balloon never inflated.The devices were removed successfully as a unit with no patient injury.It is uncertain exactly when and where the balloon damage occurred.New devices were used, and the valve was successfully implanted.The patient is stable post procedure.

Manufacturer Narrative

The delivery system was not returned to edwards lifesciences for evaluation.In addition, no relevant imagery was provided for review.Due to the unavailability of the device, no manufacturing non-conformances were identified during the evaluation.During the manufacturing process, the delivery system was visually inspected and tested several times.The balloons are 100% dimensionally inspected for any defects.During final inspection, 100% distal to proximal visual inspection is performed by both manufacturing and quality.Flex catheters and balloon catheters are 100% leak tested.Furthermore, the delivery system was tested and inspected on sample devices from each lot under a sampling basis during product verification (pv) testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history review (dhr) was performed and did not reveal any manufacturing non=conformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints relating to delivery system leakage.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.A review of the risk management documentation was performed, and 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 for delivery system leakage was unable to be confirmed as neither the complaint device nor applicable imagery was provided for evaluation.A review of dhr, lot history, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.As no patient or procedural imagery was provided, a definitive root cause is unable to be determined at this point.However, it is possible that interactions with potential calcification found in the patient's access vessel may have damaged the balloon during the procedure.It is also possible that potential excessive manipulation of the device during valve alignment or tracking through the patient's anatomy may have led to delivery system damage and the reported leakage and inability to fully inflate the balloon.However, without the return of the device, there is insufficient information available to determine a definite root cause.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation and corrective/preventative actions are not required.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to section g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• 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: 11363273
• MDR Text Key: 249090747
• Report Number: 2015691-2021-01380
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)220910(10)63407910
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 63407910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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