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

Model Number 9600LDS23A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Failure to Align (2522); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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 prior to a transfemoral tavr procedure, it was noted that pre-existing vascular stents were present in both the right common iliac artery (rcia) and left common iliac artery (lcia).The dilator and 14fr.Esheath were advanced through the right femoral artery and stent without complications.Resistance was encountered during the advancement of a 23mm sapien 3 valve and commander delivery system.The valve was advanced with force and brought into the abdominal aorta for alignment.The gross alignment was performed without issue; however, during the fine adjustment, the fine adjustment wheel would not complete the balloon alignment.The fine adjustment wheel and lock mechanism were reset multiple times without success.The decision was made to pull the delivery system/valve back into the sheath and withdrawal the devices.The delivery system, valve and sheath were withdrawn as a unit, but became ¿stuck¿ in the rcia stent.Vascular surgery was called and an open abdominal approach to extract the delivery system and repair the vessel was performed.During the preparation of a second sheath and delivery system, the patient became unstable.The tavr procedure was aborted without the deployment of a sapien 3 valve.At the time of the report, the patient was alive.

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.Review of case imagery and photographs of the device following removal from the patient revealed the valve was not aligned on the inflation balloon after the delivery system was removed from the patient and the balloon pleats appeared to be ¿disturbed¿.The vascular stents removed from the patient appeared to be potentially damaged from the withdrawal difficulties of the delivery system and sheath.Review of the patient 3mensio indicated calcification present in the access vessels and a minimum luminal diameter (mld) of 3.9mm.The case cine showed the delivery system was unable to be retrieved from the patient¿s right access vessel.The video of the fine adjust tested outside of the patient¿s body showed the dial moving, but no adjustment made near the balloon/flex tip region.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other complaints related to the trend categories.Complaint history review from april 2019 to march 2020 for the commander delivery system (all models and sizes) revealed additional returned complaints related to the appropriate trend categories.A review of the complaint history revealed that the occurrence rates did not exceed the march 2020 control limits for the trend appropriate trend categories.Per the ifu and training manuals slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.Note: fine adjustment wheel functions only when the balloon lock is locked.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and the flex catheter tip during valve alignment.To correct: move to a different straight section of the aorta (for diving only).If using a balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.Perform valve alignment in the straight section of the aorta during the manufacturing process multiple 100% inspections and testing are performed on the delivery system components and final devices.The delivery system undergoes 100% final distal to proximal inspection.Additionally, functional and tensile product verification (pv) testing is performed on a sampling basis.All tested units passed pv testing.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.In this case, the complaints were confirmed based on imagery/cine review.Due to unavailability of device, the presence of a manufacturing non-conformance was unable to be confirmed.Review of dhr, lot history, and complaint history showed no indication a manufacturing non-conformance contributed to the complaint event.Per the complaint event description, ¿the delivery system, valve and sheath were withdrawn as a unit, but became ¿stuck¿ in the rcia stent.¿ contact with additional components throughout the patient¿s anatomy such as stents may lead to unintended attachment leading to the delivery system catching onto the stent and leading to additional friction felt by the user.Additionally, the 3mensio showed calcification on the access vessels that may have led to additional strain on the delivery system during withdrawal.As such, procedural factors (contact with stent and calcification) may have contributed to the reported withdrawal difficulties.Although a root cause for the fine adjust difficulties could not be confirmed, it is possible that procedural factors such as excessive fluid in the balloon during fine adjustment may have led to the reported incident.The balloon pleats appear disturbed potentially due to residual fluid left in the balloon during device preparation.Residual fluid can alter the balloon profile and reduces the amount of movement that the delivery system can move thus leading to fine adjust difficulty.Additionally, patient factors such as calcification, tortuosity and small mld can also contribute to fine adjust difficulty.Calcification, tortuosity, and small mld limit the amount of space available to navigate through the vasculature and can cause tension buildup during fine adjustment.Procedural factors (residual fluid left in balloon) or patient factors (tortuosity/calcification/ small mld in vasculature) may have contributed to the fine adjust difficulties.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 9845613
• MDR Text Key: 191580516
• Report Number: 2015691-2020-11003
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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: 12/03/2021
• Device Model Number: 9600LDS23A
• Device Lot Number: 62621776
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/28/2020; 07/23/2020
• Supplement Dates FDA Received: 04/28/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention