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

Model Number 9600LDS23A

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4). investigation is ongoing.

Event Description

As reported, during transcatheter aortic valve replacement (tavr) with a 23 mm sapien 3 valve via subclavian approach, valve alignment was unable to be align and then blood was noticed in the inflation device.The physician had trouble retracting to view the white line and then could not adjust further with fine adjustment. the valve and delivery system was removed.A new s3 valve was prepped on a new commander system and deployed successfully with mild paravalvular leak at 60/40 deployment.The device was discarded by the facility.

Manufacturer Narrative

The delivery system was not returned to edwards lifesciences for evaluation.  in addition, no imagery was provided by the site.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, presence of a manufacturing non-conformance was unable to be determined.During manufacturing, the delivery system is both visually inspected and tested several times throughout the process.Additionally, the work order underwent product verification testing as a requirement for lot release.Of note, no failures occurred during product verification testing of the lot samples and the lot was released.  these inspections during the manufacturing process support that proper inspections of the devices are in place to detect issues related to the complaint events.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was not performed as there was no evidence of a product non-conformance related to the complaint.  a review of the complaint history was not performed as the complaint was not confirmed.Additionally, the occurrence rate did not exceed the control limits for the trend categories.The complaints for delivery system leakage, delivery system difficulty with valve alignment, and handle fine adjust difficulty were unable to be confirmed.A review of dhr and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Additionally, a review of the ifu and training manual revealed no deficiencies.There was no note of device leakage during device preparation, suggesting that there was no issue with the device when removed from packaging.The following patient/procedural factors can result in difficulty with valve alignment:  performing valve alignment at a bend or angle can cause the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can cause resistance while performing valve alignment and/or fine adjustment.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces; residual volume left in the balloon could enlarge the inflation balloon profile and create interference with the valve during valve alignment, which subsequently led to increase in valve alignment forces.This was recreated in a previously performed engineering study; improper crimping of the valve onto the balloon.The valve may not be crimped to the appropriate size or may have been damaged during the crimping process.If high valve alignment forces occurred, excessive manipulation and force was likely applied to counter the forces, and may have resulted in device damage, leading to the reported device leakage.In addition, high valve alignment forces would also contribute to fine adjust difficulties.As a result, available information suggests patient and/or procedural factors (valve alignment in non-straight section/residual fluid/improper crimping/excessive force and/or device manipulation) may have contributed to the reported complaint events.Since no product non-conformances or labeling/ifu deficiencies were identified and the occurrence rate did not exceed the complaint control limit, neither a product risk assessment escalation, nor corrective/preventive is not required at this time.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 8476347
• MDR Text Key: 140920864
• Report Number: 2015691-2019-01154
• Device Sequence Number: 1
• Product Code: NPT
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 9600LDS23A
• Device Lot Number: 61769841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 05/08/2019; 07/23/2020
• Supplement Dates FDA Received: 05/13/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1