MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS29A

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure with a 29mm sapien 3 valve in the aortic position, the balloon would not inflate properly despite the physician pushing extremely hard on the atrion, it would not fully inflate.Then the balloon would not come down and after several attempts a 60cc syringe was connected to the sideport of the delivery system and it deflated.It was clarified that during the case, while attempting to cross the valve with the delivery system, there was a significant amount of torque put on the system to get it to cross the native valve.After removal of the initial delivery system a second system was prepped and reinserted into the patient.This system achieved full expansion and the valve was placed without issue.Per the field clinical specialist, there was no slow inflation/deflation time noted during prep.The approximate time of inflation/deflation during deployment was 10-15 seconds to inflate.Deflate was similar.The device was torqued 1-2 rotations.There were no kinks noted.The perceived root cause for the inflation/deflation difficulty was the potential kink in the system due to torquing.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: component code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, and no image evaluation was performed as no imagery was provided.A visual inspection was performed, and the following was observed: flex tip had gouges.32ml liquid in atrion.Inflation balloon unpleated.No other damaged or abnormalities observed.Functional testing was performed, and the following was observed: upon receiving, the balloon was inflated and deflated using the returned non-edwards stopcock and atrion.The balloon was could fully inflate with no balloon leakage or damage observed.Additionally, the returned device was evaluated for balloon inflation/deflation time to simulate transcatheter heart valve (thv) deployment.The measurements met the specification.Due to the nature of the complaint, no applicable dimensional testing was able to be performed.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 this adverse event is not required at this time.The complaints were unable to be confirmed as no applicable procedural imagery was provided for evaluation and the reported complaint could not be replicated from the returned device.No manufacturing non-conformance was identified during the evaluation.A review of the device history records and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.As reported, "the balloon would not inflate properly despite the physician pushing extremely hard on the atrion it wouldn't fully inflate.The balloon wouldn't come down and after several attempts physician finally put a 60cc syringe on the side port and it deflated." additionally, "the perceived root cause for the inflation/deflation difficulty was the potential kink in the system due to torquing." under these conditions, the patient's anatomy can present difficult bend angles or constrained condition resulting in torquing of the system and higher resistance for the delivery system to overcome during tracking and subsequently affecting inflation and deflation.If the delivery system is twisted, kinked, torqued, or excessively rotated due to tortuous anatomy, it can impede the flow of fluid to the inflation balloon during thv deployment, which may have resulted in the observed difficulties during inflation and deflation of the balloon.A definitive root cause is unable to be determined.However, available information suggests that patient (tortuosity) and procedural factors (excessive manipulation (torquing) may have contributed to the complaint event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.Therefore, no corrective or preventative action nor product risk assessment escalation is required at this time.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• 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: 15188747
• MDR Text Key: 297491422
• Report Number: 2015691-2022-07209
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240229(10)64262331
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64262331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male