MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26

Device Problems Difficult to Insert (1316); Failure to Align (2522); Positioning Problem (3009); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pneumonia (2011)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during a transfemoral procedure of a 26 mm sapien 3 valve in the aortic position resistance was felt when inserting the commander delivery system through the 14fr esheath.During valve alignment in the straight section of the aorta, the valve moved when the flex tip was retracted, and it moved forward.The valve alignment was not able to be performed.The valve was placed in the descending aorta.A 2nd valve was implanted in the aortic position.Per report, the operator confirmed that the valve was crimped correctly.The patient is in the hospital recovering from a pneumonia.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.No photo or imaging was provided.During manufacturing, the following visual inspections and test are performed throughout the process per procedure.Inflation balloons are 100% visually and dimensionally inspected.Prior and after the balloon, pleat, fold and forming process the balloons are 100% inspected for defects.The flex tip outer diameter is 100% dimensionally inspected.The delivery system is functionally tested during the manufacturing process.During final inspection, the entire device is visually inspected distal to proximal by both manufacturing and quality for defects.In addition, product verification (pv) testing is performed on a sampling basis for lot release.The test includes visual inspection for kinks, or cracks.These inspections during the manufacturing process make it unlikely that a defect in manufacturing contributed to the complaint event.No failures occurred during product verification testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformance issues that may have contributed to the complaint event.A lot history was reviewed and did not reveal other similar complaints for this reported event.A review of complaint history revealed that the occurrence rate did not exceed the may 2020 control limit for all the trend categories.The commander delivery system ifu, prepping manual and procedural training manual were reviewed for instructions or guidance for proper use of the commander delivery system.The procedural training manual provides guidance on delivery valve alignment.Factors that assist with valve alignment are as follows: unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock, check delivery system before valve alignment.If kinked, do not use, re-lock the device after unlocking every time, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, and if additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.Note, do not position the thv past the distal valve alignment marker, this will prevent proper thv deployment, perform valve alignment in the straight section of the aorta, compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct valve alignment issues: move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.It is additional noted that 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.Based on the review of the ifu and training manual, no deficiencies were identified.The complaint was unable to be confirmed due to no device returned or imagery provided.No manufacturing non-conformances were identified and review of available information (lot history, and dhr) did not identify any evidence of manufacturing non-conformances.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint event.Additionally, no training/ifu deficiencies were identified.Based on prior complaints with similar complaint codes, valve movement can occur due to tension built-up in the system and related to patient anatomy (tortuous pathway) or procedural factor (valve alignment in non-straight section or residual fluid in balloon).Performing valve alignment at a non-straight section of the aorta can cause the thv to unseat from the flex tip (non-coaxial placement of the valve in relation to the flex tip) during alignment and ¿dive¿ int o the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can result in unusual valve alignment forces, and can create tension in the system in order to achieve final alignment position.Similarly, residual fluid left in balloon prior to valve alignment and deployment can cause the distal end of the balloon to expand, therefore displacing the valve proximally once the flex tip is retracted to the triple marker band (and no longer aligned within the valve alignment markers).Under simulated conditions (simulated tortuous anatomy/residual fluid), a previously performed engineering study was able to recreate high valve alignment forces.However, based on the complaint description, valve alignment was performed in a straight section of aorta and patient did not have difficult/calcified access vessel.Additionally, procedural imagery was not provided, therefore the suggested root cause could not be confirmed.In this case, a conclusive root cause was unable to be determined to confirm the complaint event.However, procedural factors (device manipulation) may have contributed to the reported event.No device nonconformance or labeling/training/ifu deficiencies were identified during evaluation.Additionally, the complaint occurrence rate for the applicable trend category did not exceed may 2020 control limits.Therefore, no product risk assessment nor corrective and preventative action is required at this time.

Manufacturer Narrative

A supplemental mdr is being submitted for information provided during the device pre-deco observation.The section of this report has been updated: h10 (narrative text).During engineering observation of the delivery system, the balloon shaft was stretched proximal to the stop of the sleeve.During inflation of the balloon port, leakage was observed from the side port.During flushing of the side port, leakage from the balloon port "y" connector was observed.

Manufacturer Narrative

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

Manufacturer Narrative

A supplemental mdr is being submitted as the delivery system was returned for evaluation.The following sections of this report have been updated: d10 (date device returned to manufacturer), h6 (evaluation codes [result and conclusion]) and h10 (narrative text).The commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: crimp balloon was observed twisted with the inflation balloon wrinkled and uneven gouge marks were seen on the flex tip.Functional testing was performed to determine if the balloon was able to deploy evenly and leakage was observed through the side port.The handle was disassembled and found the balloon shaft material was stretched and damaged proximal to the stop sleeve.Dimensional testing was not performed due to the condition of the retuned device.During manufacturing, the following visual inspections and test are performed throughout the process per procedure.The crimp and inflation balloons are 100% visually and dimensionally inspected.Prior and after the balloon, pleat, fold and forming process the balloons are 100% inspected for defects.The commander delivery system is 100% leak tested.The flex tip outer diameter is 100% dimensionally inspected.The delivery system is functionally tested during the manufacturing process.During final inspection, the entire device is visually inspected distal to proximal by both manufacturing and quality for defects.In addition, product verification (pv) testing is performed on a sampling basis for lot release.The test includes visual inspection for kinks, or cracks and de-airing.These inspections during the manufacturing process make it unlikely that a defect in manufacturing contributed to the complaint event.No failures occurred during product verification testing.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformance issues that may have contributed to the complaint event.A lot history was reviewed and did not reveal other similar complaints for this reported event.A review of complaint history revealed that the occurrence rate did not exceed the may 2020 control limit for all the trend categories.The commander delivery system ifu, prepping manual and procedural training manual were reviewed for instructions or guidance for proper use of the commander delivery system.The procedural training manual provides guidance on delivery valve alignment.Factors that assist with valve alignment are as follows: unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock, check delivery system before valve alignment.If kinked, do not use, re-lock the device after unlocking every time, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, and if additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.Note, do not position the thv past the distal valve alignment marker, this will prevent proper thv deployment, perform valve alignment in the straight section of the aorta, compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct valve alignment issues: move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.It is additional noted that 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.Based on the review of the ifu and training manual, no 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.The complaint for valve movement on balloon was unable to be confirmed as no imagery was provided.However, the evaluation of the returned device revealed a balloon shaft cracked.No manufacturing non-conformances were identified and review of available information (lot history, and dhr) did not identify any evidence of manufacturing non-conformances.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint event.Additionally, no training/ifu deficiencies were identified.Based on the complaint, during the valve alignment, the valve moved forward over the balloon about 50% when the flex tip was retracted.While it was reported that the valve alignment was performed in the straight section of the aorta, the uneven flex tip gouges observed in figure 3 shows sign of ¿valve diving¿, where part of the crimped valve slides into the flex tip lumen.This indicates that the valve alignment may have been performed at a bend angle instead and may be related to patient anatomy factors.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces, leading to tension build-up within the delivery system.The subsequent release in tension from flex tip retraction could then have contributed to the observed valve movement.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Due to no leakage reported from the site, the damage on balloon shaft was likely occurred post valve alignment/deployment.Damage to the delivery system may have been caused by excessive manipulation during withdrawal.Per case notes, the retrieval of the entire system (including the valve) was difficult.It is possible that the delivery system was torque or rotated while attempting to pull the partially deployed valve back to the descending aorta for deployment.The excessive manipulation during this step could have resulted in balloon shaft damaged.The double twists seen on the crimp balloon further support that excessive manipulation was applied to the delivery system during withdrawal.In this case, a conclusive root cause was unable to be determined to confirm the complaint event.However, procedural factors (excess device manipulation) may have contributed to the reported event.No device nonconformance or labeling/training/ifu deficiencies were identified during evaluation.Additionally, the complaint occurrence rate for the applicable trend category did not exceed may 2020 control limits.Therefore, no product risk assessment nor corrective and preventative action is required at this time.However, a product risk assessment (pra) was previously initiated for valve movement on balloon.To address this issue corrective actions were implemented as part of a capa.The pra documents the potential for valve embolization, which did not occur during this event.The re-escalation threshold for this issue was not exceeded and the monthly trend category control limit was not exceeded.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10123955
• MDR Text Key: 194181444
• Report Number: 2015691-2020-12082
• 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,Followup,Followup,Followup
• Report Date: 05/14/2020

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: 02/03/2022
• Device Model Number: 9610TF26
• Device Lot Number: 62968323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 07/29/2020; 10/13/2020; 07/23/2020
• Supplement Dates FDA Received: 07/08/2020; 08/05/2020; 10/15/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR