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

Model Number 9600LDS29J

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Difficult to Remove (1528); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two mdrs being submitted for this case.The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

As reported by the edwards japan affiliate, during a transfemoral tavr with a 29mm sapien 3 valve in the aortic position, during valve alignment, there was difficulty when pulling the commander balloon catheter due to severe aortic tortuosity and the balloon of the delivery system was "torn".It was considered that the commander delivery system with the sapien 3 valve could not be pulled into the esheath.Thus, the sapien 3 valve was deployed in the descending aorta with a non-edwards balloon aortic valvuloplasty (bav) balloon.It was assessed that to re-perform transaortic valve replacement transcatheter aortic valve replacement (tavr) via transfemoral approach was difficult.An access vessel injury was noted, and a stent-graft placement was performed.The procedure was completed without valve deployment in the native aortic position.This case was reported as serious with the serious criterion of "hospitalization or prolonged hospitalization".Additional information received: significant tension was applied to the balloon catheter due to severe tortuosity.Thus, the balloon catheter could not be pulled until part of warning marker was visible.The cause of balloon "torn" was severe tortuosity.The sapien 3 valve was partially expanded with the "torn" commander delivery system balloon and then the delivery system alone was removed.Non-edwards bav balloon was inserted along the stiff wire and dilated the sapien 3 valve.The vessel injury occurred in the area between the right common iliac artery (cia) and the right external iliac artery (eia).Difficulty was experienced during delivery system withdrawal.The delivery system was carefully pulled and removed.The degree of calcification from abdominal aorta to thoracic aorta was severe.The area between the right cia and the right eia was narrow due to calcification.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, an imaging evaluation was unable to be performed as no imagery was provided.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.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 neither the complaint device nor applicable procedural imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the device history record and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaint.As reported, "when valve alignment was attempted, it was difficult due to severe tortuosity from abdominal aorta to thoracic aorta." it is possible that tension may have been introduced onto the system leading to the reported valve alignment difficulties.As "severe" tortuosity was reported, it is possible for valve alignment to be performed in a non-straight section, if valve alignment was performed in a tortuous (non-straight section) 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 transcatheter heart valve (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.Furthermore, as difficulties with valve alignment were reported, it is possible that the combination of high alignment forces and manipulation of the device may have caused the valve to puncture the balloon, resulting in the observed leakage.However, without applicable patient/procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient (tortuosity) and/or procedural factors (valve alignment in non-straight section, excessive manipulation) may have contributed to the complaint event.As reported, "difficulty was experienced during delivery system withdrawal.The delivery system was carefully pulled and removed".Per the field clinical specialist, "the degree of calcification from abdominal aorta to thoracic aorta was severe.The area between the right common iliac artery and the right external iliac artery was narrow due to calcification." undersized access vessels, tortuosity, and calcification can create challenging pathways and non-coaxial withdrawal angles that may have contributed to the distal end of the delivery system catching onto the sheath tip.However, without applicable patient/procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient (calcification, tortuosity, undersized access vessels) and/or procedural factors (noncoaxial withdrawal) may have contributed to the complaint event.The instructions for use (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.No device or labeling problem was identified during the evaluation.Therefore, no corrective or preventative actions nor product risk assessment escalation is required.

Event Description

On the night of the tavr procedure, the patient complained of abdominal pain and a blood test showed findings of suspected intestinal necrosis.On the morning of the postoperative day (pod) one (1), a ct showed decreased intestinal blood flow.Intestinal necrosis due to superior mesenteric artery occlusion was considered and thus emergent intestinal resection and colostomy were performed.On the same day, during acute management at ccu, the patient died due to multiple organ failure.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-11090.The investigation is ongoing.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESICENCES; 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: 16443772
• MDR Text Key: 310272280
• Report Number: 2015691-2023-11109
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194883
• UDI-Public: (01)00690103194883(17)230323(10)63675109
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: 9600LDS29J
• Device Lot Number: 63675109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 93 YR
• Patient Sex: Male