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

Model Number 9750CM29J

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 medwatch reports.Investigation is ongoing.H3 other text : no information on return of device.

Event Description

As reported by our edwards lifesciences japanese affiliate, during a transfemoral tavr procedure with a 29 mm sapien 3 ultra resilia valve, valve alignment difficulty occurred because the valve was not at the balloon marker and 'valve diving' was observed.Valve diving was solved by releasing accumulated tension in the catheter, but the valve was still out of balloon marker.An attempt was made to extend the aorta by inserting a lunderquist wire via a pigtail from the contralateral side, but the situation did not change.Valve alignment was attempted to performed at ascending aorta but it did not work.Upon negative pressure was applied with the inflation device, bleeding was observed, delivery system (ds) balloon rupture was suspected and the decision was made to abandon tavr procedure.The operator was unable to insert the valve to the sheath.The valve which was out of sheath and sheath were withdrawn together.Detachment was observed at common femoral artery (cfa), no low blood pressure (bp) was observed due to access vessel injury.A second kit was opened and sheath was inserted.The valve was deployed with nominal volume without any complication.No paravalvular leak (pvl) was observed.After deployment of the valve, left coronary artery stenosis was observed and percutaneous coronary intervention (pci) was performed for the left main trunk (lmt).Bp dropped to 50/33mmhg and vasopressors were administered.Bp rose to 200/122 mmhg and was controlled by pacing.Intravascular ultrasound (ivus) was performed to check the condition of lower limbs, a vascular dissection from the cfa to the renal artery bifurcation was observed.Further angiography of the aortic arch showed that the dissection was likely to extend continuously to the ascending aorta.An ascending replacement was performed.The procedure was completed, and the patient left the operation room.

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 added.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for valve alignment was unable to be confirmed as no imagery or device were returned for evaluation.Available information suggests procedural factors (valve alignment in the non-straight section, built up tension) likely contributed to the event as the event description stated, ''valve alignment difficulty occurred because the valve was not in balloon marker and 'valve diving' was observed.Valve diving was solved by releasing accumulated tension in the catheter, but the valve was still out of balloon marker'.If valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused 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 was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially led to the reported valve alignment difficulties.The complaint for delivery system leakage was unable to be confirmed as no imagery or device were returned for evaluation.Available information suggests procedural factors (excessive manipulation) likely contributed to the event as the event description stated there was valve alignment difficulty due to tension in the delivery system.High forces on the system during valve alignment may result in interaction between the crimped valve and delivery system balloon damaging it prior to thv deployment.It is also possible that excessive manipulation was used to overcome any tension may have resulted in damage to the balloon or delivery system that caused the reported leakage.The complaint for inability to withdraw system with valve through sheath was unable to be confirmed as no imagery or device were returned for evaluation.Available information suggests procedural factors (non-coaxial withdrawal) may have contributed to the event.It is possible that non-coaxial alignment may have resulted in the crimped thv interacting with the sheath, causing the withdrawal difficulty.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18861751
• MDR Text Key: 337183022
• Report Number: 2015691-2024-01887
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217353
• UDI-Public: (01)00690103217353(17)250413(10)65017092
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29J
• Device Lot Number: 65017092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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 Age: 72 YR