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

Model Number 9610TF29

Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  Injury  

Event Description

As reported from our affiliates in (b)(6), this was a case of a 29mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.A thrombus with aneurism was detected before the procedure and the chance for difficulties/challenges was a risk.Despite this, it was decided to do the procedure.The valve was implanted without any reported issue.However, when retrieving the commander delivery system, the balloon part could not be retrieved further then the lowest part of abdominal aorta, just before the bifurcation.Due to the pull force applied, the balloon tore at the i/c bond, and the system had to be removed surgically.Post procedure, the patient's leg was circulated, and he was awake and extubated, but required post operative follow up.As per medical opinion, the root cause was calcification and very difficult location to cross with the system.It was believed that the aneurysm was the reason the system could not be retrieved.

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in norway, this was a case of a 29mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.A thrombus with aneurism was detected before the procedure and the chance for difficulties/challenges was a risk.Despite this, it was decided to do the procedure.The valve was implanted without any reported issue.However, when retrieving the commander delivery system, the balloon part could not be retrieved further then the lowest part of abdominal aorta, just before the bifurcation.Due to the pull force applied, the balloon tore at the i/c bond, and the system had to be removed surgically.Post procedure, the patient's leg was circulated, and he was awake and extubated, but required post operative follow up.As per medical opinion, the root cause was calcification and very difficult location to cross with the system.It was believed that the aneurysm was the reason the system could not be retrieved.During pre-decontamination of the received valve, the commander delivery system distal tip was separated.It was confirmed that this happened inside the patient.

Manufacturer Narrative

Updated h6- type of investigation and investigation findings.Corrected h6- investigation conclusions.The returned devices were visually inspected, and the following was observed: distal end of delivery system separated with balloon spring stretched distally.Distal end separated with inflation balloon material bunching distally over nose tip, indicative of withdrawal difficulties.Proximal strain relief bunching against distal strain relief, indicative of tension during withdrawal.Adhesive present on both ends of balloon spring.Adhesive present within distal nose tip.Imagery provided was evaluated, and the following was observed: distal end of delivery system surgically removed from patient.Inflation balloon material observed bunching distally over nose tip.Aneurysm present within patient anatomy based on the distal tip separation at the inflation/crimp balloon bond with inflation balloon material bunched distally over nose tip, the complaints can be confirmed.The complaints for withdrawal difficulty, balloon torn, and distal tip separation were confirmed based on evaluation of the returned complaint device.However, no manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history, manufacturing mitigations and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.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.As reported, "a thrombus with aneurism was detected before the procedure and the chance for difficulties/challenges was a risk.Despite this, it was decided to do the procedure.The valve was implanted without any reported issue.However, when retrieving the commander delivery system, the balloon part could not be retrieved further than the lowest part of abdominal aorta, just before the bifurcation.Due to the pull force applied, the balloon tore at the i/c bond, and the system had to be removed surgically".Per the case notes, calcification was present within the patient's anatomy.Additionally, per the case notes confirms thrombus with an aneurysm was present within the patient's anatomy.The presence of thrombus, aneurism, and calcification can contribute to patient tortuosity and create complex withdrawing angles for the delivery system.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment (pra).As identified in the pra, tortuosity in the access vessel can create non-coaxial withdrawal angles, resulting in the distal end of the delivery with crimped valve to catching onto the sheath tip, as evidenced by inflation balloon material bunching distally.As a result, it is possible that excessive manipulation was used to overcome the felt resistance (evidenced by bunched strain relief), leading to the tearing of the inflation balloon to crimp balloon bond and subsequent stretching of the balloon spring and detachment of the distal nose tip component from the delivery system.Available information suggests that patient (tortuosity) and/or procedural factors (non-coaxial withdrawal, withdrawal of torn balloon, excessive manipulation) may have contributed to the reported event.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.No corrective or preventative actions are required.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14015491
• MDR Text Key: 288620632
• Report Number: 2015691-2022-04849
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 63883840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR