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

Model Number 9750CM20A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The esheath, valve, and delivery system were attempted to be removed.They were unable to pull the 20mm valve back into the esheath.The team had to apply amply manual pressure in attempts to remove the system from the tissue tract in the groin.The team decided to put the patient to sleep and perform a cutdown to remove the devices.No damage was reported/noted on the esheath.No vascular injury was reported, only the cutdown to remove the devices.A new 14 fr.Esheath was inserted and a new 20mm thv ds and valve were advanced and deployed without any issues.A new sheath, delivery system and 20mm sapien 3 ultra valve were used to complete the procedure without issues.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The devices were returned.The device was visually inspected, and the following was observed: 3 kinks were observed on the proximal balloon shaft, with one at the warning marker, one between the warning and default markers, and the final one at the default marker, no abnormalities noted on the sheath, the valve was observed to have exposed struts through skirt, the valve was observed to have bent outflow struts and deformed/canted frame.During post-decontamination evaluation, the following functional testing was performed: sample guidewire was passed through the delivery system, resistance noted when going over kinks on proximal balloon shaft, locking/unlocking was unable to be performed successfully.As the delivery system was attempted to lock and unlock, tension was not released on balloon shaft, delivery system hub was x-rayed, and no abnormalities noted, delivery system handle was taken apart and the retaining ring was observed to be unseated from the collet locking spring assembly and rest of assembly was unassembled.Due to the nature of the complaint, no dimensional testing was 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 confirmed based on evaluation of the returned device, and a confirmed product non-conformance was identified as the retaining ring was not fully seated within the collet locking spring assembly 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 complaints.A review of the ifu and training materials revealed no deficiencies.As reported, "during gross valve alignment, while in the straight section of the aorta, the balloon catheter was unable to be completely pulled back to the white markers.The balloon catheter would not move freely back through the delivery system (ds)." additionally, "the ds was able to advance across the native valve without issue, but upon pulling the pusher back to the 3 markers, the pusher was unable to be pulled back." during evaluation of the returned device, it was observed that the retaining ring within the handle was unseated from the collet locking assembly and had slipped over the lip feature found on the pusher.During the manufacturing process the spring is loaded together with the piston pusher and retaining ring which holds the assembly under compression.If the retaining ring is no longer engaged to the pusher, the spring assembly length will increase due to release of spring force.This elongated spring may then push against the pusher component, causing it to be constantly engaged with the collet component and as a result, the balloon shaft locking mechanism will perpetually be engaged even if the device is in the unlocked state.This may result in the reported inability to perform gross alignment, as well as the reported resistance with flex shaft prior to valve deployment.A review of the manufacturing mitigations (100% inspection during in process assembly and final inspection to test the functionality of the locking/unlocking mechanism) suggest the collet locking assembly was in its proper configuration when the device was built.As such, the damage may have stemmed from handling of the device during transit, or device preparation.The damage can happen if the retaining ring is not fully seated during the subassembly manufacturing process, making the assembly susceptible to falling apart.Available information suggests that a manufacturing defect (retaining ring of collet locking spring assembly unseated) may have contributed to the complaint.As reported, "while removing the system, the ds became stuck on the wire." during evaluation of the returned device, several kinks were noted on the balloon shaft proximal to the hub.It is possible that excessive force and manipulation were applied during reported difficulties with valve alignment, causing a kink on the proximal balloon catheter.This could result in the reported resistance with the guidewire during attempts to withdraw of the device.Available information suggests that procedural factors (excessive manipulation) may have contributed to the complaint event.As reported, "the team was unable to pull the 20mm valve back into the esheath.The team applied manual pressure in attempts to remove the system from the tissue tract in the groin and a cutdown to remove the devices." per returned imagery, tortuosity was present in the patient's access vasculature.Tortuosity in the access vessel can create non-coaxial withdrawal angles.It is possible that the non-coaxial withdrawal configuration may have resulted in the crimped valve catching on the sheath tip, contributing to the withdrawal difficulty reported.Available information suggests that patient (tortuosity) and/or procedural factors (non-coaxial withdrawal) may have contributed to the complaint.However, a definitive root cause was unable to be determined.The complaint was confirmed and product non-conformance was confirmed.Available information suggests that a manufacturing defect (retaining ring of collet locking spring assembly unseated) may have contributed to the complaint event.Although this is a low severity of the issue, due to other complaints of this type, an investigation has been opened to determine the root cause and implement any necessary corrective actions.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 further corrective or preventative actions or product risk assessment are required at this time.

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the field clinical specialist, this was a tf tavr with a 20mm sapien 3 ultra valve and commander delivery system (ds) in the aortic position.During gross valve alignment, while in the straight section of the aorta, the balloon catheter was unable to be completely pulled back to the white markers.The balloon catheter would not move freely back through the ds.The team troubleshooted by locking the system, unlocking and trying again, but without success and used the fine adjust wheel to achieve complete valve alignment.The operator was able to pull past the warning marker.The ds was able to advance across the native valve without issue, but upon pulling the pusher back to the 3 markers, the pusher was unable to be pulled back.Leaving the wire in place, the team decided to remove the ds with valve.While removing the system, the ds became stuck on the wire.The team was unable to pull the 20mm valve back into the esheath.The team applied manual pressure in attempts to remove the system from the tissue tract in the groin and a cutdown to remove the devices.No damage was noted on the esheath.No vascular injury was reported.A new 14f esheath was inserted and a new 20mm delivery system and 20mm sapien 3 ultra valve were advanced and deployed without any issues.

• 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: 13891615
• MDR Text Key: 287836693
• Report Number: 2015691-2022-04591
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)230602(10)63835154
• 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,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: 9750CM20A
• Device Catalogue Number: 9750CM20A
• Device Lot Number: 63835154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/17/2022; 06/10/2022
• Supplement Dates FDA Received: 04/12/2022; 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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
• Patient Sex: Female