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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(4), during implant of a 29 mm sapien 3 valve in the mitral position via transseptal approach the valve was unable to fully deploy due to delivery system leakage.The delivery system and valve were removed without issue.No valve was implanted.The patient was doing well post procedure, however later expired.Additional information requested was not forthcoming.

Event Description

Upon second valve deployment, the valve did not expand completely due to delivery system leakage during the attempt to implant.Therefore, the delivery system and valve had to be removed through the femoral artery by endovascular surgeons.No surgery was needed.

Manufacturer Narrative

The investigation remains ongoing.

Manufacturer Narrative

The product was not returned for evaluation.Imagery provided by the site shows the valve on the inflation balloon partially out of the non edwards sheath.The inflation balloon is bunched up with the valve struts partially expanded and bent outwards.Leakage can be noted on the crimp balloon as liquid can be seen leaking from the region distal to the end of the balloon shaft.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing process, the delivery system is visually inspected and tested several times.During manufacturing, the delivery system balloon was 100% inspected.During the final inspection the delivery system underwent 100% inspection by both manufacturing and quality.Additionally all manufacturing lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported 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 torn was confirmed based on the provided imagery.Investigation of complaint history, dhr and lot history review revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As mentioned in the description ¿when the physicians tried to pass the valve through the atrial septum, there was resistance and they inflated a bit the bottom of ew commander balloon (the valve was crimped on it) with the objective of increasing the size of the puncture site in the septum.¿ it is possible that by inflating the balloon in this manner the balloon material became damaged either by coming into contact with patient anatomy or from pressure build-up when inflating in the septum.As such when attempting to withdrawal the partially inflated thv back into the septum and out of the patient, additional force was likely applied as evidenced by the bunching of the inflation balloon leading to the balloon damage propagating and tearing radially.While a definitive root cause is unable to be determined, available information suggests that procedural factors (improper use of thv for dilating septum/withdrawal of partially deployed valve/excessive manipulation) may have contributed to the complaint events.The complaint was confirmed, but no manufacturing nonconformance was identified during the evaluation.No labeling/ifu/training inadequacies were identified.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

Event Description

The patient was initially doing well post procedure however, expired later in the hospital due to cardiogenic shock with severe acute mitral regurgitation.

Manufacturer Narrative

Additional information received b5 updated.The investigation remains ongoing.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11140991
• MDR Text Key: 227072671
• Report Number: 2015691-2021-00060
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1