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

Model Number 20000ISM

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 02/22/2024

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.H3 other text : device remains implanted.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position.During procedure, air embolism was suspected, but no air bubbles were seen in echo.Patient presented in overall good condition with no abnormalities before the procedure.As reported, patient became hemodynamically unstable after the implant system (is) left the guide sheath (gs) in the left atrium.The blood pressure briefly dropped below 40 mmhg systolic and medication was administered.The patient became stable again after a few minutes.A search was made for a possible cause, but nothing was found.The device was flushed properly and without any problems.No air was drawn during aspiration and no st elevation was noticed during the case.The procedure could then be continued normally without complications.As per one proctor present, a short-term irritation of the conduction system was also suspected.Starting mitral regurgitation (mr) grade was 4, and final mr grade was 1.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h6 and h11 the complaint for inadequate aspiration, air remaining in device during insertion was confirmed with other empirical evidence.No manufacturing non-conformities were found in the investigation.Available information suggests the device may have led to an air embolism or a short-term change in the conduction system that may have contributed to the reported event.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: 18913647
• MDR Text Key: 337776822
• Report Number: 2015691-2024-02057
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241106
• 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: 04/23/2024

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: 20000ISM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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