MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : not returned.

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra valve in aortic position.During inflation of the 26mm sapien 3 ultra valve, the commander balloon ruptured.The balloon was fully inflated during the balloon rupture.The balloon was then retracted into the esheath.At the access site, there was significant resistance and the device could not be removed from the body.Manual compression of the artery was performed and vascular surgery was called to perform a cut down.Following the cut down, the device was removed.It appeared that the balloon did not rupture longitudinally.The "bunching" of the balloon material was causing the increased resistance to remove the device.It is hypothesized that the balloon ruptured due to the heavy calcification of the stj per the implanting physician.Following successful cut down on the rt.Femoral artery, there was a dissection noted in the distal external illiac.The surgeon and implanter agreed to not intervene at this time.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.Balloon burst: the complaint for "balloon burst" was unable to be confirmed due to lack of device return or applicable imagery.Available information suggests calcification likely contributed to the event as the customer reported that "it is hypothesized that the balloon ruptured due to the heavy calcification of the stj per the implanting physician." the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Difficulty or inability to withdraw system through vasculature: the complaint for "difficulty or inability to withdraw system through vasculature" was unable to be confirmed due to lack of device return or applicable imagery.Available information suggests that withdrawal of burst balloon likely contributed to the event as the customer reported that "there was significant resistance, and the device could not be removed from the body." the customer also stated that -the "bunching" of the balloon material was causing the increased resistance to remove the device." as the balloon was burst, the altered balloon profile could have made it more susceptible to catch on patient vasculature which would have then led to the experienced retrieval difficulty.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18167448
• MDR Text Key: 328478431
• Report Number: 2015691-2023-17606
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250628(10)65182775
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 65182775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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 Sex: Female