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

Model Number 9750CM23A

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Death (1802); Tissue Damage (2104)

Event Date 02/11/2020

Event Type  Death  

Manufacturer Narrative

Udi: (b)(4).This is one of two manufacturer reports being submitted for this case.The investigation is underway.

Event Description

As reported by a field clinical specialist, during the procedure of a 23 mm sapien 3 ultra valve in the aortic position via transfemoral approach the valve was unable to pass through the sheath.Moderate patient tortuosity was observed.All the devices were removed as a unit.No injury to the patient was reported.Access to the groin was closed.Another 23 mm sapien 3 ultra valve, commander ds with ultra loader, and esheath were prepped and access was obtained in the aortic position via subclavian approach.The ultra valve and commander delivery system (ds) were advanced distal to the sheath end and prepared for valve alignment.There was some angulation noted between the valve and the distal end of the delivery system flex cath.The valve was aligned on the balloon with no apparent difficulty.During the 1st attempted inflation, the entire volume of the atrion inflation syringe (17cc) was deployed with no visual change in the ds balloon on cine.The atrion was filled with an additional 17cc and inflation was repeated, again with no visual confirmation of balloon inflation.Negative pressure was applied to the atrion with visual aspiration of blood into the atrion.At this point balloon rupture or leak was suspected and the valve was never inflated.The decision per md was to try and remove the ds while using the e-sheath to strip the valve off of the ds, keeping the ultra valve in the body secured by the guidewire.Subsequently the commander device was removed.A non-edwards valvuloplasty balloon (vp) was inserted over the wire and through the undeployed ultra valve.The vp balloon was inflated resulting in partial expansion of the ultra valve.Another inflation using the vp balloon was attempted resulting in further, but not complete expansion of the ultra valve.The decision was made to remove the vp balloon.At this point it was noted that the vp balloon was stuck on the valve and unable to be easily withdrawn.During further attempts to remove the vp balloon the patient decompensated and passed away.It was reported the cause of death was due to pea.Upon inspection of the commander ds following the procedure, a "small tear" was observed in the shaft of the balloon catheter.

Manufacturer Narrative

Additional information g3 updated and stated this report is related to medwatch number: mw5093228.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2020-10802.The product was not returned for evaluation.Photographs provided by the site shows the device after being used in the procedure.A pinhole is unable to be identified, however there is evidence of blood inside the balloon, which could indicate a leakage.Imagery (ct scan still frames) showed the patient having calcification and tortuosity present in the subclavian access vessel.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.A review of complaint history from march 2019 through february 2020 revealed additional returned complaints for the commander delivery system (all models and sizes) for balloon leakage.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes. the similar complaints review revealed that no manufacturing issues were identified in the returned products.Available information suggested that procedural factors and/or patient factors may have contributed to the similar events.The complaint history review revealed that the complaint occurrence rate did not exceed the february 2020 control limit for the applicable trend category.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the edwards commander delivery system with s3u and no deficiencies were identified.Per ifu user should advance the catheter and use the flex wheel, if needed, and cross the valve.As necessary, utilize the flex wheel to adjust the co-axiality of the valve and the fine adjustment wheel to adjust the position of the valve.Before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.During the manufacturing process, the commander delivery system is visually inspected and tested several times.During manufacturing, the delivery system was 100% inspected.During the final inspection, the delivery system underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 balloon leakage was confirmed based on photographs provided.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.Review of the lot history, dhr, and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As mentioned in the description ¿per medical opinion, when the valve came out of the sheath, valve aligned normally, annulation due to patient¿s anatomy moderate tortuosity.¿ the procedure was performed in the subclavian access vessel which had tortuosity present.It is possible that the valve and delivery system flex tip remained coaxially aligned upon retracting the sheath tip while keeping the delivery system in place.However, prior to or during valve alignment, the valve could have become canted in relation with the flex tip due to the vessel tortuosity.This is supported by additional notes from the field, ¿valve/ds was advanced distal to sheath end and prepared for valve alignment.Some angulation noted between the valve and the distal end of the delivery system flex catheter.¿ as such it is possible that tortuosity in the patient caused the non-coaxial alignment of the valve and the delivery system, causing the valve to potentially dive into the flex tip.As a result, the balloon material can be more prone to damage due to the interaction of the angulated valve and the delivery system, which eventually led to the leakage observed.While a definitive root cause is unable to be determined, available information suggests that patient (tortuosity) and/or procedural factors (non-coaxial alignment between devices) may have contributed to the complaint events.The complaint for balloon leakage was confirmed.However, no manufacturing nonconformance were identified during evaluation.A definite root cause was unable to be determined at this time, but it is possible that patient (tortuosity) and/or procedural factors (non-coaxial alignment between devices) contributed to the reported event.There were no manufacturing non-conformances, labeling, training, or ifu deficiencies identified, and the occurrence rate did not exceed the trending control limits.Therefore, no corrective and preventative action nor product risk assessment escalations are required at this time.

Manufacturer Narrative

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

• Brand Name: COMMANDER DELIVERY SYSTEM WITH ULTRA LOADER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9792894
• MDR Text Key: 182170467
• Report Number: 2015691-2020-10801
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 9750CM23A
• Device Lot Number: 62778299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR