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

Model Number 9610TF23U

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-15281.Investigation is ongoing.

Event Description

As reported by the edwards european affiliate for a 23mm sapien 3 ultra case by transfemoral approach.While advancing the commander delivery system with crimped valve through the esheath, it got stuck and could not be pushed any further.The valve was past the transition part of the esheath.The decision was made to remove the esheath and commander with valve together as a unit.Upon inspection of the commander delivery system and esheath, it was seen that a part of the valve frame had perforated the sheath shaft, most likely due to a bent frame strut.A new esheath and commander delivery system were prepared, and the valve was successfully implanted with a good result.The patient was doing well and suffered no adverse effects.No vascular damage was detected after a ct scan.As per pre-deco evaluation, a leakage was observed on the distal end of the commander inflation balloon.

Manufacturer Narrative

Added h.6 codes.The commander delivery system was returned after use in the procedure with the valve partially inserted into the sheath.The device was locked at the default position with no flex and fine adjust used.A full loader assembly was over the flex shaft.During visual inspection, the delivery system and valve was inside the esheath when returned, valve was stuck in the strain relief section of the sheath.The delivery system was returned with valve remained on the proximal end of the inflation balloon.During pre-decontamination evaluation, engineering partially inflated the balloon to deploy the valve and a pinhole leak was observed in the distal end of the inflation balloon, just proximal to the inflation balloon / nose tip bonding.Due to the nature of the complaint, no dimensional testing was able to be performed.The event was confirmed through visual inspection.Due to the nature of the complaint, no functional testing was able to be performed.Due to the nature of the complaint, no functional testing was able to be performed.No photographs, video or imagery was provided for evaluation.A device history record (dhr) review was performed and did not reveal any issues that may have contributed to the reported event.A lot history review was performed and revealed no complaints related to delivery system balloon leakage.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.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 instructions for use (ifu), device prep manual, and procedural training manual were reviewed for instructions or guidance for proper use of the commander delivery system.Correctly orient delivery system and check position before insertion.Orient the delivery system with the flush port pointing away and the edwards logo facing up.Ensure delivery system is locked in default position.If working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion.In expectation of high friction, use short movements and push delivery system closer to sheath hub.Push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.Following proper valve crimping technique and ensure valve is delivered as straight as possible be careful to not bend the proximal end of the sheath when inserting the delivery system through the sheath.If push force is too high or valve is initially stuck, zoom in and rotate the c-arm to ensure valve and sheath are not damaged.If damaged, retract valve in sheath slightly.Remove valve and sheath together as single unit and replace.If push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.If push force is too high or valve is still stuck, remove valve and sheath together as a single unit and replace.Do not over-manipulate the sheath at any time.Based on the review of the ifu and training manual, no deficiencies were identified.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The delivery system balloon leakage was confirmed through the evaluation of the returned device.No manufacturing nonconformance was identified during the evaluation.Based on the reviews of the dhr, lot history, and complaint history, there is no evidence to support a manufacturing non-conformance contributing to the complaint.No ifu/training material deficiencies were identified.A review of manufacturing mitigations supported that the device has proper inspection in place to detect issues related to the reported event.It is unlikely that the delivery system left the manufacturing site with balloon damage, as the balloons are 100% visually inspected at several different steps throughout the manufacturing process and devices are 100% leak tested.Additionally, there was no note of abnormalities or leakage on the delivery system during device preparation and de-airing, suggesting that there was no issue with the device when removed from packaging.The balloon leakage was identified during the pre-decontamination product evaluation.The pinhole leakage was found to be in the inflation balloon to distal nose tip bond joint.The delivery system was returned with valve remained on the proximal end of the inflation balloon (figure 3).Upon further advancement of ds/valve through the remaining length of the sheath, the valve was still remaining on the working length of the inflation balloon.Therefore, the interaction between devices that could have caused the pinhole leakage is unknown.Based on available information, a definite root cause was unable to be determined at this time.Since no edwards defect was confirmed, no preventative or corrective actions are required.Additionally, since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.

• 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: 11302210
• MDR Text Key: 252664313
• Report Number: 2015691-2021-00256
• 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: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: 9610TF23U
• Device Lot Number: 63299145
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR