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

Model Number 9600LDS29A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Unintended Movement (3026); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Investigation is ongoing.

Event Description

As reported by the field clinical specialist, the 29mm sapien 3 valve was inserted through right cfa on commander through the 16f esheath.When fine alignment was performed in the straightest section of the thoracic aorta, the distal valve marker stopped approximately 3 mm from inflow of the 29mm sapien 3.The system was reset and fine alignment appeared successful.After crossing the annulus over the safari wire, and the flex catheter was retracted above the middle marker, the 3 mm gap between the inflow and the distal valve marker was present again.The device was reset several times.Each time the flex catheter was retracted above the middle marker, the 3 mm gap appeared again.The team decided to deploy the s3 at this point.When the team inflated the balloon, the valve did not deploy indicating a balloon rupture.The commander was unflexed and retracted into the thoracic aorta and attempted to be retracted into the esheath.The outflow of the s3 appeared flared and could not be retracted into the esheath.It was hypothesized to have happened during partial inflation.The decision was made to attempt to remove the s3, the commander and the esheath together.The outflow of the esheath became caught on the arteriotomy and could not be removed.A surgical cut down was performed and the system was removed over a lunderquist wire.A second 16 f esheath was prepared to specifications and inserted.After re-crossing the aortic annulus, the 29 mm s3 was prepared to specification on commander delivery system and was aligned and deployed across annulus over lunderquist wire for a 70/30 aortic/ventricular placement.Aortography demonstrated no pvl or central ai.Hemodynamics were stable with well-defined dicrotic notch.The commander system and esheath were removed and a gore graft was placed to repair the access site.The patient was stable post-procedure and sent to recovery.The original system that was removed from the patient is being retained by the hospital for inspection and edwards will be notified when it can be retrieved.There appeared to be mild to moderate tortuosity in the aorta.The patient's mld was 9.6mm.

Manufacturer Narrative

Update to b4, g3, g6, h2 and h10 to reference related manufacturer report no: 2015691- 2021- 05883.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Update to b4, g3, g6, h2 and h10 to reference related manufacturer report no: 2015691- 2021- 05883.The 29mm commander delivery system was returned to edwards for evaluation with 16f esheath and loader cap on flex shaft.Atrion and stopcock attached to balloon port.Device was returned locked at valve alignment position with no flex or fine adjustment used.The returned devices were visually evaluated.The inflation balloon to crimp balloon bond torn with wings flared out.Valve alignment difficulty was confirmed based on heavy flex tip gouges observed.Bunching of inflation balloon material pulled towards distal end and flex shaft compression was observed proximal to flex tip.The esheath liner fully was expanded; tip opened as designed with some minor damages to soft tip.Valve alignment functional testing was performed (without balloon) successfully with no issues with gross alignment, fine adjust, lock/unlock.However, due to the condition of the returned device (balloon cut/y-connector detached at strain relief), no further functional testing can be performed at this time.Complaint confirmed based on visual inspection.Double-wall thickness measurements of the crimp balloon were taken, as an out of specification measurement could make the material more susceptible to tearing and be indicative of a manufacturing non-conformance.Measured components were within specifications.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.Multiple manufacturing mitigations are in place.Of note, no failures occurred during the product verification testing and the lot was released.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Ifu for commander delivery system, device preparation manual and device training manual were reviewed.No ifu/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.Regarding the navigation difficulty, and withdrawal difficulty, since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a product risk assessment (pra) was required.Regarding the valve movement on balloon, a pra was previously initiated to investigate the cause and assess the risk associated with valve movement on the balloon.The risks outlined in the pra remain the same; the pra documents the potential for procedural delay, which did occur during this event.The re-escalation threshold for this issue was not exceeded for october 2021(monthly trend category control limit was not exceeded).The pra remains applicable, and no further action is required.Regarding the balloon tear, per management discretion, due to the high criticality of the failure mode, the balloon torn issue and its associated risks have previously been documented and assessed in a pra.No product non-conformance was identified during the evaluation and the occurrence rate did not exceed october 2021 control limit.In this case, the material separation occurred prior to thv deployment and resulted in procedural delay and withdrawal difficulties resulting in percutaneous intervention.A pra was previously initiated to investigate the cause and assess the risk associated with 'balloon - torn'.Pra re-escalation threshold has not been exceeded.Based on this assessment, the pra remains applicable, and no further action is required.Regarding the navigation difficulty, and withdrawal difficulty, since no edwards defect was identified, no corrective or preventative actions are required.Regarding the valve movement on balloon, based on the pra, a capa was previously initiated to document the investigation and drive corrective/preventive actions as appropriate.The investigation revealed that high tension can lead to valve movement in the proximal direction when the flex catheter is retracted prior to deployment.Global refresher training was provided, emphasizing steps to reduce tension in the system that can lead to valve movement.The capa closed on january 10, 2020, with the acceptance criteria that complaint rates remained within control limits during the effectiveness monitoring period.The complaints were confirmed based on evaluation of the returned device, however the complaint for valve movement was unable to be confirmed as no applicable imaging was returned and a manufacturing nonconformance was not confirmed.A review of the device history record (dhr), lot history, manufacturing mitigations, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.As reported, 'the system was reset and fine alignment appeared successful.After crossing the annulus over the safari wire, and the flex catheter was retracted above the middle marker, the 3 mm gap between the inflow and the distal valve marker was present again.The device was reset several times'.Additionally, per imagery review, it was observed that the anatomy of the patient had tortuosity and calcification.The pra captures the prior investigation of this failure mode where high tension conditions can potentially result in proximal valve movement during flex tip retraction.Performing valve alignment in a tortuous vasculature or non-straight section of the anatomy, or with an altered balloon profile caused during device preparation steps, can result in built-up tension in the system.As the patient anatomy presented tortuosity, it is likely that some tension was released during flex tip retraction causing the valve to be mispositioned relative to the distal markers.Additionally, per ifu, 'if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary'.In this case, valve alignment difficulty may be due to perform valve alignment at non-straight section or tortuous anatomy.A definitive root cause was unable to be determined at this time.However, available information suggests patient factors (tortuosity) and or procedural factors (valve alignment performed in a non-straight section) may have contributed to the reported events.Potential root cause for separation of the inflation balloon to crimp balloon bond have been identified and documented in a pra.Potential sources of increased valve alignment forces could be residual fluid in the balloon, patient tortuosity and performing valve alignment in a non-straight section.In this case, tortuosity can create non-straight sections in the patient's vessel anatomy.Performing valve alignment in a non-straight section of the vasculature can cause the valve to 'dive' into the lumen of the flex tip where part of the crimped valve slides into the flex tip.Flex tip gouges observed may be indicative of valve diving and excessive manipulation.If the thvf is unseated (non-coaxial placement of valve in relation to the flex tip) during alignment, it can result in higher than usual valve alignment forces and it is possible that increased forces and tension could have weakened the balloon causing the balloon to tear.A definitive root cause was unable to be determined at this time.However, available information suggests patient factors (tortuosity) and/or procedural factors (valve alignment performed in a non-straight section/ excessive manipulation) may have contributed to the reported events.Additionally, the complaint description states, 'the commander was unflexed and retracted into the thoracic aorta and attempted to be retracted into the esheath.The outflow of the s3 appeared flared and could not be retracted into the esheath.It was hypothesized to have happened during partial inflation'.An attempted inflation can alter the valve profile such that valve struts flare at the outflow.It is likely that the flared struts resulted in the distal end of the delivery system catching onto the sheath tip and arteriotomy which led to the reported withdrawal inability.Available information suggests procedural factors (withdrawal of partially expanded valve) may have contributed to the reported events.However, a definitive root cause was unable to be determined at this time.A capa was previously initiated to capture additional information that currently exists in the training manuals into the ifu 'instructions for use' for the sapien 3 and commander delivery system.The content consisted of instructions related to device preparation and minimizing the tension in the device, which may potentially lead to delivery system damage during use.While the event occurred post implementation of corrective actions as documented in the capa, however, the occurrence rate did not exceed the trending control limits or the existing rmw occurrence rate, therefore no further action 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
• 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: 12685447
• MDR Text Key: 278823048
• Report Number: 2015691-2021-05882
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)230622(10)63835110
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 63835110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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 Sex: Male