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

Model Number 9600LDS29

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Difficult to Remove (1528); Device Contamination with Body Fluid (2317)

Patient Problems Mitral Valve Stenosis (1965); Injury (2348)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a valve in valve (29mm sapien 3 in 31mm surgical valve) in the mitral position due to mitral stenosis, during inflation contrast leaked out and blood filled the atrion syringe.  initially, the physician had difficulty crossing the septum and the prosthesis valve with the delivery system/valve. the pusher was pulled back, however, during inflation nothing happened. contrast was seen to be leaked out and blood filled the atrion syringe. it was determined at that moment that the balloon had failed. the delivery system/valve were retracted into the common venous system until they reached the tip of the sheath. the valve was not able to be reinserted all the way into the sheath as it had been inflated about 2%. a femoral cutdown was performed and purstrings were added/sewn into the venous system. the sheath, delivery system and valve were removed and a new 16fr esheath was prepped and inserted.  the physician was able to successfully implant a 29mm sapien 3 valve and the patient was noted to have left the room in stable condition.

Manufacturer Narrative

B7:other relevant history.

Manufacturer Narrative

Section f10, h6 and h10.  section h10: additional information provided by the hospital medical records indicated the patient was discharged on pod1 in stable condition.  the delivery system was not returned to edwards lifesciences for evaluation, as it was discarded by the facility.  imagery of the device/event was not provided.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 contributed to the reported events.As the lot number was not provided, a design history record (dhr) or a lot history review was not able to be performed.  a review of complaint history from (b)(6) 2018 to (b)(6) 2019 for the edwards commander (all models, sizes) revealed other similar complaints with returned devices for the reported events.  no manufacturing issues were identified.  available information suggested that procedural factors and /or patient factors may have contributed to the events.  a review of complaint data for (b)(6) 2019 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend categories.  the commander delivery system instructions for use, the device preparation manual, the valve-in-valve patient screening and procedural training and the procedural training manuals were reviewed for device preparation and use instructions related to the reported events.  per the procedure training manual, during the delivery system removal, ensure the balloon is completely deflated.  pull the entire delivery system through the sheath.  maintain guidewire position in the aorta.  caution: patient injury could occur if the delivery system is not completely unflexed prior to removal.  during the retrieval of the delivery system through the sheath the training manual indicates the following:  thv can be retrieved through sheath only before thv deployment (still crimped).  ensure the thv is centered on the flex tip.Ensure delivery system is locked.  verify the flex catheter is completely unflexed.  retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.  ensure the edwards logo on the sheath handle is facing upward.  withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position per complaint description, ¿initially the physician had difficulty crossing the septum and the prosthesis valve with the delivery system/valve¿.  it is likely that the difficulty experienced while attempting to cross the septum and previously implanted prosthetic valve (calcification present) may have inadvertently caused the damage to the delivery system and or balloon resulting in leakage.  per training manual instructions, the thv can only be retrieved before thv deployment.  because the valve was partially expanded, retrieval of the expanded valve profile would lead to withdrawal difficulty.  as a result, available information suggests that patient factors (calcified prosthetic valve) and/or procedural factors (excessive manipulation/partially expanded valve) may have contributed to the complaint events.However, a definite root cause is unable to be determined.  no corrective or preventative action is required.

Manufacturer Narrative

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

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8677378
• MDR Text Key: 147297455
• Report Number: 2015691-2019-02055
• Device Sequence Number: 1
• Product Code: NPU
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29
• Device Catalogue Number: 9600LDS29A
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR