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

Model Number 9610TF29

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2024

Event Type  malfunction  

Event Description

Per report received from south africa, it was a case of an implant of a 29mm sapien 3 valve in aortic position by transfemoral approach.The patient presented with severe native leaflets and stj calcification.During the procedure, with the inflation of the balloon during the 5 seconds count of fully inflated balloon, it burst.The valve was fully deployed with no impact to results of valve deployment.The ds was pulled back into the esheath three quarters of the way, and both were removed as a unit.There were no patient consequences.As per physician opinion, the root cause of the event was the severe calcium on the free edges of the leaflets, as well as on stj level.

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.The complaint for "balloon burst" was unable to be confirmed.Available information suggests that patient factors (calcification) likely contributed to the event as per event description, patient had severe degree of calcification on the leaflets and the stj.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.A technical summary applies to this complaint event and establishes, through extensive complaint investigations, that balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have been due to calcification in the landing zone or over-inflation of the balloon.In addition, the ruptured balloon profile may lead to withdrawal difficulty and/or component separation if excessive device manipulation is applied.Therefore, it is likely that these patient/procedural factors may have caused or contributed to the burst balloon during valve deployment.Review of the ifu and training materials is detailed in the technical summary and continues to provide adequate instructions on device use, risks, and precautions.In addition, review of manufacturing mitigations is captured in the technical summary, which are still in place.With no unique issues or concerns raised with this complaint, this event will be included in ongoing monitoring and trending with no pra or capa 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.H3 other text : discarded.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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 edwads way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18807657
• MDR Text Key: 336563314
• Report Number: 2015691-2024-01449
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 65210614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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 Age: 81 YR
• Patient Sex: Male