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

Model Number 9600LDS29A

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is underway.

Event Description

As reported by a field clinical specialist, during insertion of a 29 mm sapien 3 valve and commander delivery system through a 16f esheath through the femoral vein for a mitral viv procedure, resistance occurred and the esheath kinked.The patient had severe tortuosity.Attempts to advance the esheath past the tortuosity and attempts to pull the esheath back were made; however, the valve and delivery system could not be advanced.Propofol was put on the delivery system to see if it would help, but advancement could not be achieved.The valve, delivery system and sheath were removed from the patient.The femoral vein was ballooned a few times to assist the new system.A new sheath was placed and a new valve and delivery system were used successfully.The patient is currently stable.There were no issues with placing the initial esheath.A pinhole on the commander delivery system crimp balloon at the crimp marker was observed.

Manufacturer Narrative

The device was received for evaluation.The delivery system was returned after use in the procedure.The delivery system was kinked due to return packaging and was inserted into the sheath with the delivery system nose tip at the sheath strain relief.The valve was crimped on the crimp balloon.The devices were separated for decontamination and evaluation.The delivery system was visually inspected and the following was observed: a pinhole was visible on the balloon when the device was inflated and no other abnormalities observed.Functional testing was performed and when the balloon was inflated, a pinhole leak was observed on crimp balloon.Dimensional analysis was performed.Double wall thickness measurements were taken on the crimp balloon at the pinhole.The measurements meet the double wall thickness specification.Since the lot number was not provided a device history review and a lot history review could not be performed.A review of the complaint history revealed that the occurrence rate did not exceed the june 2018 control limit for the trend category of ¿leakage¿.No instructions for use (ifu) or training deficiencies were identified.Manufacturing inspections support that it is unlikely that a defect present in manufacturing contributed to the complaint.The complaint for ¿balloon ¿ leakage¿ was confirmed based upon visual inspection of the returned devices.Dimensional testing of the balloon double wall thickness met specification and visual inspection of the device did not reveal a manufacturing nonconformance.Furthermore, review of available information (complaint history) did not identify any evidence of manufacturing non-conformance.A review of manufacturing mitigation supports that the balloon and delivery system have proper inspections in place to detect issues related to the complaint event.Since the device was able to be de-aired, the observed pinhole was not present on the device out-of-box.Therefore, the damage occurred during the procedure.As noted in the cer, resistance was felt when inserting the delivery system through the sheath.This difficulty was attributed to tortuosity of the vein, in addition to the presence of scar tissue and clips from a previous procedure.It is possible that due to the resistance felt, additional force and manipulation was applied to the delivery system.The additional manipulation may have resulted in a valve strut making contact with the balloon material, and higher forces applied to the delivery system may have caused the strut to damage the balloon.A root cause is unable to be definitively determined; however, it is likely that patient factors (tortuosity, presence of scar tissue and surgical clips) contributed to the complaint.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 complaint for ¿balloon ¿ leakage¿ was confirmed.No manufacturing non-conformances were identified in the returned device.Available information suggests that patient factors (tortuosity, scar tissue, presence of surgical clips) may have contributed to the complaint event.Since no product non-conformances or ifu/training inadequacies were identified, and the trend category does not exceed control limits, 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: 7629781
• MDR Text Key: 112567949
• Report Number: 2015691-2018-02403
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS ESHEATH INTRODUCER SET
• Patient Age: 87 YR