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

Model Number 9610TF23

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by our affiliates in (b)(6), during deployment of a 23mm sapien 3 valve by transfemoral approach in the aortic position, blood was seen in the inflation syringe.The balloon was partially inflated approximately 30-40 percent when the balloon rupture occurred.New devices were used to complete the procedure.On post-operative day 1, the patient was discharged.There was no injury to the patient and the outcome was good.The patient had a heavily calcified valve.Bav was not performed.There was no additional inflation volume added.As per medical opinion, the root cause may have been due to the patient¿s heavily calcified valve.

Manufacturer Narrative

Additional information was received.Section b1, b2, and h1 were corrected.After the balloon rupture occurred, the commander delivery system balloon was cut and the valve was removed from the balloon through a surgical cut down.New device were used to complete the procedure.

Manufacturer Narrative

Imagery was provided of the device after being used in the procedure.The image shows the blood inside the atrion filled to less than the required volume, which is indicative of a possible delivery system leakage somewhere within inflation pathway of the device.The devices were not returned to edwards lifesciences for evaluation.Dhr review did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review revealed no other similar complaints.A review of the complaint history on confirmed (returned and no product returned) from january 2020 to december 2020 revealed similar complaints, but no manufacturing non-conformances 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.Initiate rapid pacing ensuring.Confirm placement of center marker within optimal initial.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.Additional considerations: verify flex tip is on triple marker to ensure full inflation of balloon during deployment and ensure stability of delivery system during thv deployment.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.If considered, reposition only at the very early stage of deployment.Do not exceed 20 seconds for inflation and deflation of the delivery system.Always maintain control of the plunger of inflation maintain control of the plunger of inflation device when releasing it.Never lock the inflation device during bav or thv deployment.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.Severe ihss including septal hypertrophy: thv movement aortic.Based on the review of the ifu and training manual, no deficiencies were 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-conformance's contributed to the reported events.The complaint was confirmed based on provided imagery.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing nonconformance was unable to be confirmed.Reviews of the dhr, complaint history review, lot history review and manufacturing mitigation's did not provide any indication that a manufacturing non-conformance contributed the complaint.A review of the ifu and training manuals revealed no deficiencies.Per complaint description ¿when inflating the balloon in order to implant the valve, blood was seen in the atrion inflation syringe¿.As the valve was unable to be deployed, it is unknown at what point in the procedure the damage occurred (during valve alignment, tracking over the arch, or during valve deployment).However, it was stated that there was heavy calcification present within the native valve.It is possible that during inflation the balloon came in contact with calcium nodules penetrating the balloon and delivery system resulting in the leakage observed.Available information suggests that patient factors (calcification) could have contributed to the complaints.However, without a device for evaluation, a definitive root cause was unable to be determined.The complaint for delivery system ¿ leakage was confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that patient factors (calcification) may have contributed to the reported event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor 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.

• 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: 11216112
• MDR Text Key: 232858900
• Report Number: 2015691-2021-00229
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 9610TF23
• Device Lot Number: 63143551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR