MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number 20000GSA

Device Problem Air/Gas in Device (4062)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

Edwards received notification of a pascal in mitral procedure where the guide was prepped per protocol.The tech did remove back syringe while feeding wire through introducer and when aspirated, air was noted from tubing.Then the physician advanced more to ensure we were past seals and checked the stopcock, but the air still remained.It was suggested to remove and try another, but the physician said he would rather just not flush.There was no harm that occurred during or after this event.Patient had labile hemodynamics on 0.1 mcg of norepi with swinging bp from 90 to 280 systolic.Tachycardia was up to 110 throughout the case, not tolerating anesthesia.Over 1l of fluid was given which inflated the gradient to 7.The team discussed that once optimized, the gradient would fall back down along with la pressure.Additional information received from clinical specialist confirmed that no air was seen on imaging that could have caused the reported hemodynamic changes.Patient's blood pressure issues were unrelated to air in device but instead related to a new anesthesia provider along with patient fluid volume status and patient response to medications.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(6).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h3, h4, h6 and h10 the complaint for inadequate aspiration, air remaining in device during insertion.Was confirmed with other empirical evidence as the continuous air was unable to be replicated during aspiration.Upon initial aspiration testing the device was able to be aspirated normally.After the unit was dried, it was subjected to leak testing as is performed in manufacturing and the unit failed to meet the leak specification indicating the presence of a leak path.Upon breaking down the unit and performing a visual inspection it was also noted that there was blood present in the space between the guide sheath catheter and the structural spine component.Further visual inspection noted that though there was blood in the space, the critical bond which seals off the catheter did indeed meet 360 adhesive coverage specification.Once the unit was subjected to simulated use testing, it was able to be prepared and aspirated normally and continuous air was not visualized as indicated in the event description.Though the device did not show the same failure as was observed in the case, the presence of the blood in the spine to shaft space as well as the failure to pass leak test when the unit was dried signal potential bond delamination resulting in a leak path between the catheter shaft and structural spine.Delamination in this region can create very small leak pathways that can become occluded with liquids if ejected with enough force or pressure into the space.In the instance of failed leak test results but passing aspiration, it is believed the leak pathways may have become occluded during flushing as part of the normal prep procedure or from residual liquid migrating into the space prior to aspiration.Though the findings suggest delamination to be the potential cause of failure, it is unclear how the delamination could have occurred in this unit between time of manufacturing (passed all leak tests and inspections) and time of use.Bond delamination can occur due to many factors including inadequate curing of the adhesive, decay over time, environmental/physical conditioning, or heat conditioning, however a definitive root cause has not been determined.The sample failed leak standard pascal leak testing at 1.2 psi in both instances: with and without the introducer inserted just past the seals.Failure in the leak tests indicates a presence of a potential leak path.When the guide sheath was further challenged in a leak test at 10 psi for characterization, it failed leak test without the introducer but passed in the trial with the introducer inserted past the seals.No labeling, training, or ifu deficiencies were identified through investigation.A pra and a capa have been initiated for further assessment.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 18359954
• MDR Text Key: 331196645
• Report Number: 2015691-2023-18541
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Model Number: 20000GSA
• Device Lot Number: 65212579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/25/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1