MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY, 26MM; AORTIC VALVE PROSTHESIS, PERCUTANEOUS DELIVERED

Model Number 9600LDS26J

Device Problems Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 10/18/2022

Event Type  Injury  

Event Description

As reported by our edwards japanese affiliate, during a transfemoral transcatheter aortic valve replacement (tavr) in the native annulus, the right coronary artery was damaged and pericardial effusion was observed.The 26mm commander delivery system was inserted along the safari guidewire.A sapien 3 valve did not pass through the aortic valve, the passage angle was changed by releasing the flex catheter and the safari guidewire came out of the left ventricle.An attempt was made to pass the aortic valve by the wire, the wire entered the right coronary artery, and eventually, a pericardial effusion was observed.The delivery system was removed.The pericardial effusion was minimal, and the patient's vital signs were intact.A decision was made to implant the sapien 3 valve.After deployment of the sapien 3 valve, the pericardial effusion had increased.A pericardiocentesis was performed and the patient was transferred for post management care.Per the medical opinion, the patient had the horizontal aorta, it was difficult to pass through the aortic valve.In addition, the loss of the safari guidewire was due to not having a good grip on the wire.

Manufacturer Narrative

The investigation is ongoing.The device will not be returned.

Manufacturer Narrative

Update to b1 (type of report), h2, h6 (component code, device code, type of investigation, investigation, and investigation conclusions) and h10 to reflect engineering evaluation.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record review was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the reported event.The commander delivery system ifu (instructions for use), device preparation manual and device procedural manual were reviewed for guidance and instructions.The device procedural manual provides guidance on crossing native valve.Do not force the thv, use short movements to prevent 'jumping' of the thv into the ventricle, and use rao or ap projection to ensure wire position is maintained in the ventricle.Factors that make it difficult to cross are heavy calcification, wire bias into commissure, horizontal aorta, tortuous thoracic aorta, flex catheter kinked and inadequate bav.When experiencing difficulty crossing, make sure the wire is correctly extended at the apex, pull tension on the wire or reposition, add some distal flex or remove some partial flex and pull the system back and re-advance.No ifu or training deficiencies were identified.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 complaint for difficulty or inability to cross native annulus and/or bioprosthesis was unable to be confirmed as the complaint device and /or applicable imagery were not returned.Due to 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.A review of 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.Per training manual, 'sapien 3 valve did not pass through the aortic valve due to horizontal aorta, it was changed the passage angle by releasing the flex catheter, the safari guidewire came out of the left ventricle unexpectedly.' per the medical opinion, 'it was impossible to insert the delivery system into an aortic valve due to patient factors such as severe calcification on ncc and horizontal aorta.' a horizontal aorta can create sub-optimal bend angles, contributing to difficulty navigating and crossing the native valve.Additionally, the presence of calcification cause interaction between the advancing delivery system with thv and calcified nodules present, obstructing the valve crossing and resulting in the reported difficulty crossing the native annulus.In this case, available information suggests patient (calcification, horizontal aorta) contributed to the reported event.However, a conclusive root cause was unable to be determined at this time.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 product risk assessment no corrective or preventative action is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY, 26MM
• Type of Device: AORTIC VALVE PROSTHESIS, PERCUTANEOUS 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: 15765281
• MDR Text Key: 303392695
• Report Number: 2015691-2022-09144
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194876
• UDI-Public: (01)00690103194876(17)240613(10)64431703
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS26J
• Device Lot Number: 64431703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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 Age: 80 YR
• Patient Weight: 48 KG