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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4) the investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6) during deployment of a 29mm sapien 3 valve in the aortic position by transfemoral approach, the balloon did not open and the contrast medium was observed to be leaking from the balloon.The valve was removed through the sheath and a new valve and delivery system were used to successfully implant the valve.There was no consequence to the patient.The patient was doing fine after the procedure.

Manufacturer Narrative

During the pre-decontamination evaluation on the returned devices, a pinhole on the proximal shoulder of the inflation balloon was observed.Section f10 (device codes) were corrected.The investigation is ongoing.

Manufacturer Narrative

Procedural imagery was provided by the complaint.A video was provided of the delivery system during thv deployment.The inflation balloon was unable to inflate with contrast observed to leak proximal to the thv.Calcification was present in the aortic annulus.The devices were returned to edwards lifesciences for evaluation.During visual analysis it was observed the valve was aligned on inflation balloon, and a pinhole was observed on proximal shoulder of inflation balloon.During function testing, inflation was attempted by engineering which showed a leak was present.No other functional testing could be performed due to the damage.The complaint ¿balloon - leakage¿ was confirmed.Dimensional analysis was not able to be performed.Dhr review did not reveal any issues that would have contributed to the complaint event.Lot history review revealed no other similar complaints.A review of the complaint history from aug 2019 to july 2020 for the edwards esheath introducer set revealed other similar complaints, no manufacturing nonconformance were identified.The ifu, device preparation training manual, and procedural training manual were reviewed for instructions/guidance for preparation and use of the devices: per the procedural training manual, thv deployment: check to ensure: thv is exactly between the valve alignment markers.Flex tip is on the triple marker.Balloon lock is locked.Perform thv deployment: unlock the inflation device o initiate rapid pacing ensuring 1:1 capture, sbp = 50 mmhg, and pulse pressure < 10mmhg.Confirm placement of center marker within optimal initial center marker zone.Begin initial deployment with a slow controlled inflation.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon.Stop pacing and withdraw the balloon from the native valve.Do not exceed 20 seconds for inflation and deflation of the delivery system.Factors that may affect the thv deployment characteristics: narrow, calcified stj: thv movement ventricular and/or reduced foreshortening of the thv.Thv oversizing: reduced thv foreshortening.Incomplete thv expansion: reduced foreshortening of the thv.Note: the delivery system requires a prescribed volume for thv deployment and proper function balloon rupture: if delivery system balloon ruptures of leaks during deployment without thv embolization: do not use excessive force.Take care when crossing the thv, tracking over the arch and removing the delivery system (through the tip of the sheath).Maintain guidewire position.Check for pv leaks under echo.If post-dilation needed, use a new delivery system.No ifu/training deficiencies have been identified.During manufacturing of the 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-conformances contributed to the reported events.The complaint for ¿balloon ¿ leakage¿ was confirmed based on the condition of returned device.However, investigation of the device, complaint history, lot history and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.A review of manufacturing mitigations supported that the delivery system has proper inspections in place to detect issues related to the complaint 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.In addition, there was no reported difficulty during device preparation.As no resistance was observed during valve alignment, it is unlikely that negative valve interaction with the balloon (from non-coaxiality/tortuous anatomy) caused the observed damage on the returned device.As observed in the provided imagery, there was calcification present in the aortic annulus.Presence of calcification can create a challenging anatomy for the balloon to navigate during placement in the annulus.It is possible that the inflation balloon caught on calcification during positioning resulting in the balloon damaged and the inability to inflate the balloon.Available information suggests that patient factors (calcification) may have contributed to the complaint events.However, a definitive root cause is unable to be determined.The complaint for ¿balloon ¿ leakage¿ was confirmed.No manufacturing non-conformances were found in the evaluation.A definite root cause was unable to be determined at this time, but it is possible that patient factors (calcification) may have contributed to the reported events.Since no product non-conformances or ifu / training inadequacies were identified, no corrective and preventative action nor product risk assessment is required at this time.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.

Manufacturer Narrative

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

• 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: 10360144
• MDR Text Key: 202720423
• Report Number: 2015691-2020-12916
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 9610TF29
• Device Lot Number: 62708210
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR