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

Model Number 9610TF20U

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

As reported, it was a case of an implant of 20mm edwards sapien 3 ultra transcatheter heart valve, in aortic position.During procedure, the valve and balloon were noted not to be aligned properly and a bend was observed at the delivery system pusher.The devices were removed and new devices were opened,.The procedure was completed.No patient injury.During preliminary decontamination, balloon leak was noticed at the proximal shoulder of the inflation balloon.

Manufacturer Narrative

The event date is unknown.The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 and investigation conclusions and investigation findings.Added new information to h.6 component codes and type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Esheath received with delivery system + crimped valve inserted.Delivery system returned in lock position.Fine adjustment 100% used.Flex indicator in straight position.Valve received crimped over the inflation balloon area.Imagery was provided from the site and revealed the following: compression in flex catheter during attempts to align thv over markers and valve movement on balloon observed during attempt to withdraw flex tip from thv.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed by evaluation of the returned device and imagery review.However, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''the valve and balloon were noted not to be aligned properly and a bend was observed at the delivery system pusher''.Valve alignment difficulty in cine imagery provided by the field, it was observed that the valve was not able to be fully aligned over the valve alignment markers using fine adjust, and the flex shaft showed signs of compression.Although no mention of tortuosity in patient anatomy was reported, it is still possible for valve alignment to be performed in a non-straight section.If valve alignment was performed in a non-straight section of vasculature, this can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and ''dive'' into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of ''diving'' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.Thv moves on balloon it is possible that tension built up within the system during valve alignment was released during withdrawal of the flex tip from the thv, resulting in the crimped thv moving proximal onto the inflation balloon as observed.Potential root causes for tension build up leading to valve movement on balloon have been identified and documented in product risk assessment (pra).As identified in the pra, valve alignment in non-straight section of anatomy and tortuosity of patient vasculature may have contributed to tension build up in the system and resulted in the observed valve movement on balloon.Balloon leak excessive force may have been applied during the attempts at valve alignment to overcome the reported resistance.Excessive force may have resulted in the observed compression of the flex shaft and the reported system component damage.Additionally, excessive force may have caused the struts of the crimped thv to impinge on the inflation balloon during valve alignment, possible damaging the balloon and resulting in the observed inflation balloon leak observed during device evaluation.A definitive root cause was unable to be determined at this time.However, available information suggests patient (tortuosity) and/or procedural factors (valve alignment in non-straight section, excessive force, built up tension) contributed to the reported event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 16104030
• MDR Text Key: 308420205
• Report Number: 2015691-2023-09988
• Device Sequence Number: 1
• Product Code: NPT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: 9610TF20U
• Device Lot Number: 64106405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1