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

Model Number 20000GS

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H6- clinical code- hemodynamic instability.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where the patient had a high tricuspid insufficiency (ti) and a high mitral insufficiency (mi).Patient also had edema in the legs and pleura effusion.At the beginning of the procedure the heart rate (hr) was 100 bpm, and the blood pressure (bp) was 95/60 mmhg with high venous pressure.The preparation of the gs and is was according to ifu with no issues.After the transeptal puncture, the hcp put the guide sheath (gs) inside the la and the device was pulled inside the gs (around 25-30cm).The hcp aspirated with the syringe, but it did not work smooth, so the flush port was turned from the gs from 3oclock to 5-6 oclock and released flex on the gs and then the aspiration worked well.During this aspiration, the anesthesiology notified a reduced blood pressure from 95mmhg to 45 mmhg.After 5 minutes, the bp raised again to 110 mmhg after medical therapy.The device was advanced to the la and closed it.The hcp wanted to put the la pressure measurement on the sc, and he aspirated through the flush port.He aspirated some water, blood but also air.There was around 10 ml of air in the syringe.After some minutes the patient condition starting deteriorating.The blood pressure fell again to 40 mmhg, hr raised to 130-150 bpm.The device and the gs were taken out because it was needed to reanimate the patient.The patient was reanimated around 2-3 minutes and after some medical therapy the blood pressure was around 110 mmhg.The hcp checked coronary arteries but did not find any abnormalities.At the end of this event, the hcp said to the clinical specialist (cs) that the common problem could be the patient's high ti and the pleura effusion.The doctor even mentioned that the patient was not in good condition to be treated with teer.The patient went to intensive care and will be checked.At the time the cs left the hospital, the patient was still asleep and under medical treatment to raise the blood pressure.On pod 3, the patient was stable and not in intensive care anymore.As per medical opinion the event was most likely a hemodynamic event related to a reduced volume and reduced rv function which led to a reduced stroke volume.Additionally, the doctor mentioned that it was not device related and more to the general patient status.

Manufacturer Narrative

The complaint for inadequate aspiration, air remaining in device during insertion was unable to be confirmed.No manufacturing non-conformities were found in the returned sample at this time.Available information suggests that variations in execution of procedural steps may have been a contributing factor.However, a definite root cause is unable to be determined.

• 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: 18296723
• MDR Text Key: 330113708
• Report Number: 2015691-2023-18250
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20000GS
• Device Lot Number: 65212586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female