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

Model Number 9750CM26A

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Injury (2348); Pericardial Effusion (3271)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(6).Investigation is ongoing.

Event Description

As reported, during a transfemoral transcatheter aortic valve replacement (tavr) procedure with a  26mm sapien 3 ultra valve, prior to crossing, the patient¿s pressure dropped and was put on pump.  a tee noted an effusion and the effusion was drained successfully.There was a left ventricular (lv) bleeding due to a wire perforation.  upon removal of the delivery system, the valve was stuck and there was withdrawal difficulty.  a cut down was performed at the left femoral head to remove the system.  the patient left the room in stable condition.

Manufacturer Narrative

The delivery system was not returned to edwards lifesciences for evaluation.  in addition, no relevant imagery was provided for review.  due to unavailability of the device, engineering was unable to be perform any visual, functional, or dimensional analysis; therefore, a manufacturing nonconformance was unable to be determined.During the manufacturing process, the delivery system was visually inspected and tested several times.  inflation balloons are 100% inspected for any defects.  the flex shaft was 100% visually inspected for physical damage.100% distal to proximal visual inspection by both manufacturing and quality.Additionally, the work order underwent product verification testing.  all testing passed specification for lot release.  these inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was performed and revealed no additional similar complaints for delivery system withdrawal difficulty.A review of the risk management documentation was performed and 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 complaint for delivery system withdrawal difficulty valve through sheath was unable to be confirmed.  a review of dhr, lot history, manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Per report, ¿upon removal of the delivery system, the valve was stuck [despite the coaxial alignment between the delivery system and sheath tip], and there was withdrawal difficulty.A cut down was performed at the left femoral head to remove the system.¿ it is possible that the crimped valve was caught on the sheath tip during retrieval attempts, leading the user to withdraw the device down to femoral head without re-sheathing the crimped valve and then surgically remove the device.Patient factors such as calcification (if present) could impact the ability to retrieve the valve into the sheath.During system retrieval, the interaction between the crimped valve and calcification (if any) could distort the frame, leading to increase profile and higher chances for the valve being caught on the sheath tip.However, without patient anatomy information or applicable imagery, the suggested root cause could not be confirmed.There is insufficient information to determine a root cause at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation and a corrective/preventative actions are not required.

Manufacturer Narrative

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: 10362330
• MDR Text Key: 202395897
• Report Number: 2015691-2020-12918
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 9750CM26A
• Device Lot Number: 63118414
• Was Device Available for Evaluation?: No
• 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