MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC25

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 10/27/2022

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in mexico.As reported, this was a case of a valve-in-valve implant of a 26mm sapien 3 into an unknown edwards valve, in tricuspid position by transfemoral approach.During the procedure, a pre-dilatation was performed due to heavy calcification on the valve's leaflets.A 25 mm edwards balloon catheter was used.The native valve inner diameter was 26 mm, the physician accessed by the femoral vein and advanced a lunderquist guide wire that was placed on the right pulmonary branch.The physician proceeded to pre-dilatate the valve first with a 16 mm balloon catheter followed by the edwards 25 mm balloon.During the inflation, the balloon burst.When removing the balloon catheter out of the patient, resistance was felt, and physician realized that the tip of the balloon had torn off and still inside the patient.With the help of two snares, the physician took out the missing tip of the balloon, no harm or instability on the patient was presented during the failed pre dilatation or the tip recovery.A second 25 mm ew balloon was used to perform a successful pre-dilatation this time and the valve was delivered successfully.The patient was stable during all-length procedure and there was no patient injury.The patient was discharged.As per medical opinion, the root cause of the event might be related to the heavy calcification of the tricuspid valve.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Imagery was provided and the following was observed: the balloon ruptured radially.The distal tip separated.A video revealed that the balloon burst upon full inflation.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.The complaints of balloon burst, withdrawal difficulty, and distal tip separation was confirmed by visual inspection of the returned imagery.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of dhr did not provide any indication that a manufacturing non-conformance contributed to the event.An existing edwards' technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As reported, ''during the procedure, a pre-dilatation was performed due to heavy calcification on the valve's leaflets.'' additionally, per medical opinion, ''the root cause of the event might be related to the heavy calcification of the tricuspid valve.'' the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation 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.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.Since no edwards defect was identified, no corrective or preventative action is required.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.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• 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: 15844183
• MDR Text Key: 304109828
• Report Number: 2015691-2022-09410
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 9350BC25
• Device Catalogue Number: N/A
• Device Lot Number: 64216916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: 32 YR
• Patient Sex: Male