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

Model Number 9600LDS29A

Device Problems Difficult or Delayed Positioning (1157); Failure to Align (2522); Material Split, Cut or Torn (4008); Activation Problem (4042)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.  please reference related manufacturer report no: 2015691-2020-11286.Investigation is ongoing.

Event Description

As reported, during a carotid tavr procedure with a 29mm sapien 3 valve in the aortic position, a second valve was not fully deployed due to torque in the system which caused a tear in the balloon.  the balloon became misaligned under the valve.  the patient was taken to the or for open heart surgery and both valves were explanted.

Manufacturer Narrative

The delivery system was not returned to edwards lifesciences for evaluation.  in addition, no relevant imagery was provided for review.  due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.During manufacturing, all inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.  the balloons are 100% visually and dimensionally inspected for any defects.  in addition, pv testing was performed and all passed specification for lot release.  these inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history review (dhr) and a lot history review could not be performed as work order information was not provided.  the occurrence rate did not exceed the march 2020 control limit for the trend categories.  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 complaints for delivery system difficulty with valve alignment and balloon leakage were unable to be confirmed as neither the complaint device nor procedural imagery was returned.No manufacturing non-conformance could be determined without device photos and/or device evaluation.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.No ifu/training manual deficiencies were found.Per report, ¿a second valve was attempted and it was unable to fully deploy due to torque in the system which caused a tear in the balloon.¿ torque applied to the proximal end of the balloon catheter can result in high forces/tension in the system, leading to valve alignment issues.As a result, the balloon may have become damaged when exposed to high forces/tension in the balloon.Additional information regarding the degree of tortuosity was not provided.However, as the approach in this case was transcarotid, it is possible that valve alignment was performed in a non-straight section of the vasculature, which can result in valve diving further introducing tension into the system.While a definitive root cause is unable to be determined, available information suggests that procedural factors (valve alignment in non-straight section; excessive manipulation) may have contributed to the complaint events.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation and the control limit did not exceeded the applicable trend categories, product risk assessment escalations, and corrective/preventative actions are not required.

Manufacturer Narrative

Corrected data: f10, h6.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: 9917107
• MDR Text Key: 190935270
• Report Number: 2015691-2020-11288
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/10/2020; 07/23/2020
• Supplement Dates FDA Received: 05/13/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR