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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our affiliates in new zealand, it was a 29mm sapien 3 valve implant in aortic position by transfemoral approach.During procedure, more than usual resistance was found when advancing the commander delivery system through the esheath.When deploying the valve, blood was noted coming into the inflation syringe, despite this delivery system leakage, the valve was successfully deployed.Upon removal of the commander delivery system, a small hole near the flex tip was noticed, likely caused by a kink occurred from push force on insertion of the commander delivery system.The patient outcome was good post-procedure.

Manufacturer Narrative

Supplemental report submitted to include additional information received through pre-decontamination observation.Updated h6.Per pre-decontamination observation, a pin hole on the crimp balloon was found in the area next to the bond join between balloon and balloon shaft.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined and the following was observed: kink in flex shaft at 6cm from flex tip.Pin-hole on proximal part of crimp balloon.Damage observed on flex shaft under x-ray.Double-wall thickness measurements of the crimp balloon were taken and the measurements met the specification.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 complaints of balloon leak and flex shaft damage were confirmed based on based on evaluation of returned device.However, no manufacturing non-conformance was identified during the evaluation.A review of the dhr did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.As reported, ''during procedure, more than usual resistance was found when advancing the commander delivery system through the esheath.When deploying the valve, blood was noted coming into the inflation syringe, despite this delivery system leakage, the valve was successfully deployed.Upon removal of the commander delivery system, a small hole near the flex tip was noticed, likely caused by a kink occurred from push force on insertion of the commander delivery system.'' per evaluation of the returned device, a pin-hole was observed on the proximal part of crimp balloon and the flex shaft was kinked at 6cm from flex tip.In this case, excessive manipulation may have been applied to overcome the reported resistance advancing the commander through the sheath, leading to the reported kink in the flex shaft.This kink could have interacted with the crimp balloon during valve alignment, causing the pin-hole on the crimp balloon.As such, available information suggests that procedural factors (excessive manipulation, damaged flex shaft) may have contributed to the reported leakage, while procedural factors (excessive manipulation) may have contributed to the reported kink.No device problem or manufacturing non-conformance that would have contributed to the complaint event was identified during the evaluation.No labeling/ifu deficiencies were identified.Therefore, no further escalation is required.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18956723
• MDR Text Key: 338614856
• Report Number: 2015691-2024-02199
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)250605(11)230606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2024

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 Model Number: 9610TF29
• Device Lot Number: 65116970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/25/2024; Not provided
• Supplement Dates FDA Received: 04/17/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1