MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number	ICF100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an icf100 balloon burst during an mvr case.Approximately 200 minutes into the case, the surgeon asked for the balloon pressure and was alerted that it was 70.The camera was moved to visualize the aorta and the icg9 solution was noted to be 'everywhere'.There was no patient injury directly attributed to the device burst.The unit is available for return.Er23 was used to introduce the device.No abnormalities were noted during preparation of the icf100 and there was not any difficulty encountered while inserting the device during the procedure.No unusual patient anatomy was encountered during balloon placement.Less than 30cc had been administered prior to rupture.The supplied edwards syringe was used to inflate the balloon.After rupture, the procedure was converted to open.The patient is reportedly doing fine and recovering.Additional information regarding the case was provided including the following: there were other procedural concerns leading to the conversion to open heart surgery.The balloon burst was not the only factor.The size of the aorta at the stj was 41mm.No issue in positioning device and no resistance was noted when removing the device.Device did need to be repositioned 4 or 5 times, but the amount of migration was not more than in a typical icf100 case.There was no detected material missing when the device was removed.No plaque was noted in the ascending aorta.
Additional Manufacturer Narrative
H3: pre-approved initial evaluation summary: customer complaint of balloon issue was confirmed.Balloon was observed to be ruptured.Edges of rupture site appeared to match up.Aortic root pressure lumen was found to be occluded.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Photo provided was consistent with lab findings.The reported balloon rupture can be considered confirmed through preliminary evaluation of the device.The reported event is pending review of initial evaluation as well as final evaluation and analysis.A supplemental report will be submitted accordingly once the product investigation has been completed.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Additional Manufacturer Narrative
H11: additional manufacturer narrative- updates include the following: g3 date reflects awareness of completion of product evaluation.H2 and h3 reselected to reflect current report updates.H6: type of investigation, investigation findings, and investigation conclusions updated.H11: additional manufacturer narrative: product evaluation/ investigation conclusion per product evaluation, 'customer complaint of balloon issue was confirmed.Balloon was observed to be ruptured with visible traces of blood residue.Edges of rupture site appeared to match up.Device was returned with visible traces of blood.Aortic root pressure lumen was found to be occluded.Hemostatic valve was returned detached and checked for leakage.No leakage was observed when tested as received and when attached to device.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.' per the dhr/ mitigations/ manufacturing review, 'the manufacturing data of the manufacturing lot was reviewed.No specific failures or rejects were noted for this specific lot.Lot release data and product monitoring data for this specific icf100 lot was reviewed, and no deviations could be found.A 100% leak test is executed during manufacturing of the devices.Also, the devices are tested on balloon stability pressure for 6 hours as part of lot release testing, so it is very unlikely that cause of this complaint is related to the manufacturing process.The cause of the balloon burst was not possible to be determined.' while reviewing the images provided from product evaluation, it was noted by engineering that with these images, there is an absence of the very thin, wispy edges that are seen when balloon ruptures due to material stretch and failure.The edges in this case are generally straight and look to have decent wall thickness.There are a few corners of the rupture edges that are jagged which would also indicate more of a trauma vs pure material expansion to failure.Overall, the complaint of balloon rupture was confirmed.No evidence of an edwards/ supplier manufacturing defect was found.Sufficient mitigations exist at the supplier; thus, it is unlikely to be caused by manufacturing.Based on the information available, the root cause of the balloon rupture cannot be conclusively determined.However, it was noted that the photographic evidence would suggest trauma to the device as a more likely cause than material failure.It is possible that a combination of factors contributed to the balloon rupture experienced by the customer.In addition, the ifu ((b)(4)) states, 'the balloon expands to occlude a range of aorta sizes from 20 to 40 mm.' in this case the aorta was above that range with a size of aorta at stj was 41mm.The assignable cause of operational context has been selected to reflect the difficulty of the case, the size of aorta, and evidence of possible trauma to the balloon.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8015656209
• MDR Report Key: 19610888
• Report Number: 2015691-2024-04870
• Device Sequence Number: 6334733
• Product Code: DXC
• UDI-Device Identifier: 00690103190007
• UDI-Public: 00690103190007
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2025
• Device Model Number: ICF100
• Device Lot Number: BSLC3345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female