MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM; CATHETER, FLOW DIRECTED

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.
Event or Problem Description
As reported, during this target market release (tmr) on a mitral valve & tricuspid valve replacement procedure, this hemosphere alta monitor displayed a much higher ico (intermittent cardiac output) (3.1) than corv (cardiac output right ventricle) (2.1).In addition, the rv dp/dt value was much lower (200) than echo on the tee (transesophageal echocardiography) (700).Moreover, in non-pulsatile mode, the cerebral adaptative index (cai) was intermittently and inconsistently higher than 45 not depending on procedure, although most of the time was below 45.There was no error messages displayed.The patient was not treated according to the inaccurate values provided.There was no allegation of patient injury.There will be no product return as this is a tmr.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was not returned for evaluation.Nevertheless, logs were provided for review.Based on the logs investigation, it was unable to evaluate against transesophageal echo (tee) as insufficient data was provided.Nothing indicated incorrect values for rv dp/dt.Expected device behavior for cerebral adaptative index (cai).Additionally, ico indicates that there was a bolus issue with baseline.Further investigation will be performed for this issue.Based on the available information and that the investigation did not find any device defect related to the issue of incorrect measurement, there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.

• Brand Name: HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22673544
• Report Number: 2015691-2025-06191
• Device Sequence Number: 3702178
• Product Code: DYG
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240917
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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 Model Number: ALTAALL1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown