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

Model Number 9610TF26U

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in the (b)(6), a 26mm sapien 3 ultra valve was deployed in the aortic position via the transfemoral approach.Difficulties were encountered during the insertion of the 14fr esheath.A lunderquist wire was needed to get the esheath in.Following the sheath insertion, sapien 3 ultra valve as successfully implanted.Difficulties were then encountered during the removal of the commander delivery system, resulting in a vascular injury.The surgical repair was required for the injury and the patient needed 6 units of blood.At the time of the report, the patient was doing well.The plan was to extubate the patient on postoperative day (pod) 1.Information regarding the minimum luminal diameter (mld) of the access vessels and the degree of calcification and tortuosity was not provided.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.No relevant case imagery was provided for review.The device history review (dhr) review was not able to be performed as the device lot number was not provided.Lot history review was not able to be performed as the device lot number was not provided.As the complaints were not able to be confirmed, a complaint history review was not required.The instructions for use (ifu) and training manuals have been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.During the manufacturing process, the inflation balloons undergo multiple visual and dimensional inspections.The fine adjust knob and locking collet assembly undergo multiple inspections and testing.During final inspection, the device undergoes 100% distal to proximal visual inspection by both manufacturing and quality.Functional testing is also performed.Additionally, product verification (pv) testing is performed on a sampling basis.The commander delivery system also undergoes functional pv and visual pv testing on a sampling basis.These inspections and test during the manufacturing process support that is unlikely that non-conformance contributed to the reported complaint.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.In this case, the complaints were not able to be conformed as the device was not returned and relevant imagery was not provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.A review of manufacturing mitigations supports that the device has proper inspections in place to detect issues related to the complaint events.As reported, ¿there were some issues regarding securing the pusher in the locked position [after the valve was successfully implanted]¿.Per training manual, flex tip should be positioned and locked over triple markers prior to inflation.There should be no need to tamper with locking mechanism if flex tip is properly positioned/secured prior to inflation.Furthermore, there were no reported issues with the locking mechanism during device preparation or use (e.G.Valve alignment).Without the device available for evaluation, there is insufficient information to definite root cause at this time.Difficulties were also encountered to remove the commander delivery system.The following patient/procedural factors may have contributed to the complaint event: ¿ flex tip not positioned properly along guidewire shaft triple markers o it was noted that there were difficulties securing the pusher in locked position after valve deployment.If the flex tip is not properly located over the guidewire shaft triple markers, this may lead to an increased flex tip diameter profile during retrieval through the sheath tip.Balloon shaft is not locked during retrieval o it was noted that there were difficulties securing the pusher in locked position after valve deployment.If the flex tip is not locked, the balloon shaft may move, relative to the flex shaft, during delivery system retrieval through the sheath.Non-coaxial retrieval of device through sheath tip o sheath tip positioning and/or vascular tortuosity may impact coaxility of the delivery system during retrieval through the sheath tip.If the delivery system is not coaxial with the sheath during retrieval, the delivery system may catch on the sheath tip, leading to retrieval difficulty.In this case, a peripheral vascular complication also occurred.Although a definite root cause could not be determined, procedural factors may have contributed to the reported device removal difficulties.Manipulation of the devices during the removal attempts and/or patient factors (degree of calcification not provided) of the access vessel that may have contributed to the vascular injury and subsequent surgical repair and required blood transfusions.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: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10962939
• MDR Text Key: 220163545
• Report Number: 2015691-2020-14912
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention