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

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310); Failure to Align (2522)

Patient Problems Cardiac Arrest (1762); Death (1802); Injury (2348)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported, it was a 29 mm sapien 3 case in aortic position by a left transaxillary approach.During the procedure, it was not possible to perform a complete valve alignment.Despite this, it was decided to continue with the procedure and deploy the valve.At valve deployment, the commander delivery system balloon did not inflate uniformly which led to an incomplete expansion of the sapien 3 valve.Reposition of the balloon and re-dilating the valve was not successful, therefore the patient was converted to surgery.The sapien 3 valve was explanted and a surgical valve was implanted.Also, in between procedures, the patient suffered from a cardiac arrest treated by doctors.The patient left the operating room with ecmo support but passed away on post operative day 1.As per doctor¿s opinion, the patient died due to complications related to cardiac arrest and extended cardio pulmonary bypass time.

Manufacturer Narrative

The delivery system was returned after use in the procedure.A kink was present on the balloon shaft due to return packaging of the device.A kink was present on the distal guidewire lumen and balloon, likely also due to packaging.The delivery system was partially inserted through the sheath; the devices were separated for decontamination and further evaluation.The delivery system was visually inspected flex tip gouges were observed.Cine was provided showing valve alignment and balloon inflation.Due to the transaxillary approach, valve alignment was done in a curve.The valve is not co-axial with the flex tip, and minor valve diving is visible.Prior to valve deployment, the valve is seen to be not fully aligned.There is a visible gap between the distal valve and distal alignment marker.During balloon inflation, due to the valve not being fully aligned, the valve moves proximally as the balloon is inflated.  functional testing was performed.The balloon shaft was able to be pulled to valve alignment position and locked.Full fine adjust was then able to be used with no abnormalities observed.With the balloon shaft locked at the valve alignment position, the balloon shaft was able to be pulled without any slipping observed.This meets the collet engagement force specification.Dimensional analysis was performed.The outer diameter (od) of the delivery system flex tip was measured.The delivery system flex tip is essential for stabilizing the valve during alignment, tracking, and positioning in the native annulus.A flex tip that is too large or too small may impact the ability to support the crimped valve.The flex tip od was found to be within specification.A device history review was performed and did not reveal any related issues that could have contributed to the reported events.A lot history review was performed and revealed no additional complaints for ¿delivery system ¿ difficulty with valve alignment¿.A review of complaint history from december 2017 to november 2018 for the edwards commander delivery system (all models and sizes) revealed other similar complaints for ¿delivery system ¿ difficulty with valve alignment¿ with returned devices.A review of the complaint history revealed that the occurrence rate did not exceed the november 2018 control limit for the trend category of ¿valve alignment difficulty¿.No instructions for use (ifu) or training deficiencies were identified.During manufacturing, the inflation balloon was 100% inspected, the crimp balloon component was 100% inspected, the guidewire shaft was 100% visually inspected, the balloon was 100% inspected and the assembled devices undergo 100% final inspection.In addition, each lot is required to undergo product verification tests.All lots are tested and can only be released if the product verification.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the complaint event.The complaint for ¿delivery system ¿ difficulty with valve alignment¿ was confirmed based on provided imagery.No potential manufacturing non-conformances were identified in the returned device.Performing valve alignment at a bend caused the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment.This causes the valve to ¿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 result in higher than usual valve alignment forces, and can create tension in the system in order to achieve final alignment position.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Therefore, it is likely that procedural factors (valve alignment in non-straight section) contributed to the reported valve alignment difficulty.The complaint for ¿delivery system ¿ difficulty with valve alignment¿ was confirmed based on provided imagery.No manufacturing non-conformances were identified in the returned device.Available information suggests procedural factors (valve alignment in non-straight section) contributed to the complaint event.Since no product nonconformances or ifu/training inadequacies were identified, no corrective or preventive action is required at this time.

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: 8174828
• MDR Text Key: 131332569
• Report Number: 2015691-2018-05381
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

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 Expiration Date: 07/14/2019
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 60986438
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/15/2019; 07/23/2020
• Supplement Dates FDA Received: 02/19/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR