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

Model Number 9600LDS26A

Device Problems Failure to Align (2522); Device Dislodged or Dislocated (2923)

Patient Problem Vascular Dissection (3160)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is underway.

Event Description

As reported by field clinical specialist, during implantation of a 26mm sapien 3 valve, thoracic angiogram showed retrograde dissection and lv perforation by the guidewire.Patient had abdominal tortuosity. the 14fr esheath was placed in left femoral without resistance.A bav with 23 balloon was performed.A 26 commander delivery system was advanced through the sheath and through tortuous patient anatomy into thoracic aorta for valve alignment.Gross alignment was performed, the valve was partially loaded on balloon.The delivery system locked and fine tuning was attempted; however, the fine tuning wheel was not translated to the valve. the delivery system was advanced, the system was unlocked, wheel reset, relocked, and fine adjustment attempted again.Translation to valve was not observed.The patient became hypotensive.Aortic root angiogram showed ai pigtail pulled into thoracic aorta.Thoracic angiogram showed retrograde dissection.  heart team and vascular surgery decide dissection is critical and emergent evar was necessary.An attempt to recapture valve within sheath and remove as unit was performed; however, the delivery system and sheath were removed without valve.An x-ray showed the valve in femoral artery on the wire.An evar stent graft was deployed.Patient became asystolic/no hemodynamics.Subsequently, the patient expired.It was reported that the patient¿s death was related to a lv perforation.

Manufacturer Narrative

The device was not returned for evaluation.Imagery of the patient anatomy (3mensio) was provided for review.The imagery reveals sharp bends in the aorta and abdominal tortuosity, which would make it unlikely that valve alignment was performed in a straight section.It also reveals calcification was present.  a device history review was performed and did not reveal any manufacturing related issues that would have contributed to this complaint.A review of lot history revealed no other complaint for ¿handle ¿ fine adjust difficulty¿ or ¿delivery system ¿ valve dislodged from balloon.¿ based on the review of the instruction for use (ifu) or training manuals, no deficiencies were identified.A review of complaint data for may 2018 revealed that the complaint rate exceeded the control limit for the applicable trend category (¿fine adjust difficulty¿).Although the occurrence rate exceeded the may 2018 complaint trending control limit for ¿fine adjust difficulty¿, no manufacturing non-conformances were confirmed as the device was not returned.A review of available information did not identify any product non-conformances or ifu/training manual deficiencies related to this issue.As such, a product risk assessment (pra) is not required.A review of complaint data for may 2018 revealed that the complaint rate exceeded the control limit for the applicable trend category (¿valve dislodged from balloon¿).Although the occurrence rate exceeded the may 2018 complaint trending control limit for ¿valve dislodged from balloon¿, no manufacturing non-conformances were confirmed as the device was not returned.A review of available information did not identify any product non-conformances or ifu/training manual deficiencies related to this issue.As such, a product risk assessment (pra) is not required.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.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 ¿handle ¿ fine adjust difficulty¿ and ¿delivery system ¿ valve dislodged from balloon¿ were unable to be confirmed as the device was not returned for evaluation and no relevant procedural imagery was provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, presence of a manufacturing non-conformance was unable to be confirmed.A review of the dhr, lot history, and manufacturing mitigation did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.Handle ¿ fine adjust difficulty the provided 3mensio reveals tortuosity was present throughout the patient anatomy, which would make it unlikely that valve alignment was performed in a straight section.Performing valve alignment at a bend or angle (such as in a non-straight section of the aorta) can cause the valve to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the valve is unseated during alignment, it can result in higher than usual valve alignment forces, and can create tension in the system in order to achieve final alignment position.As a result, fine adjust difficulty would be experienced.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Delivery system ¿ valve dislodged from balloon per procedural training manual instructions, during valve retrival through the sheath, the valve should be centered on the flex tip, the delivery system should be locked, and the flex catheter should be completely unflexed.In addition, the valve and delivery system should be retracted into the sheath ¿ensuring the thv is completely inside the sheath and just past the sheath tip.¿ when the patient became hypotensive and the team decided emergent evar was necessary, it is possible that the delivery system was removed quickly and the valve was noncoaxial with the delivery system during removal.If this occurred, it is possible that the valve caught onto calcification or the patient anatomy.Patient imagery reveals both calcification and tortuosity were present.In addition, if the valve was not fully retracted inside the sheath tip, the risk of the valve catching and moving off the delivery system during device removal would increase.As a result, patient and procedural factors likely contributed to the reported complaint.The complaints for ¿handle ¿ fine adjust difficulty¿ and ¿delivery system ¿ valve dislodged from balloon¿ were unable to be confirmed as the device was not returned for evaluation and no relevant procedural imagery was provided.Due to the unavailability of the device, it cannot be confirmed if a manufacturing nonconformance contributed to the reported event.However, available information suggests that patient and procedural factors likely contributed to the reported event.No labeling or ifu/training inadequacies were identified.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7540807
• MDR Text Key: 109141094
• Report Number: 2015691-2018-01978
• 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
• Report Date: 05/08/2018

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: 02/29/2020
• Device Model Number: 9600LDS26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR