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 01/29/2024

Event Type  malfunction  

Event Description

Edwards received notification of a pascal in mitral procedure where the guide sheath was aspirating air bubbles after insertion of the implant past seals and loader removed.It was verified that the device was off anatomy and even made small movements to the guide adding flex and retracting as well as advancing.The guide sheath was removed, and new guide sheath prepped and used with the same issue- there was air while aspirating.Same mitigation techniques were used but another sheath was unavailable, so the procedure was continued as normal.

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.

Event Description

Additional information received from the clinical specialist stated that there were no ekg changes and there were no issues during preparation.There were no device issues during or post implantation as well.Per case submission la pressure started at 22 and dropped to 10 post procedure.The patient was under general anesthesia, but no air was ever introduced into the patient.Also, the patient is doing fine and there were no consequences.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, b5, g3, g6, h2 and h10.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h3, h4, h6 and h11 the complaint for inadequate aspiration, air remaining in device during insertion was confirmed with objective evidence.The complaint was able to be recreated but after drying the unit, a burst of air bubbles during aspiration was observed.A minor leak was found emerging from the guide sheath pull wire, however it was not believed to be a significant contributing factor to the event as the leak was only seen under high pressure.Visual evidence of spine to shaft bond profile change before and after drying the unit points to delamination as a probable root cause.Based on the investigation, delamination of the spine to shaft bond resulted in the leak path allowing air to continuously enter the system during aspiration as detailed in the event description.This delamination can occur due to a combination of factors, however, a definite root cause is unable to be determined.Furthermore, the device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.

• 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: 18767855
• MDR Text Key: 336115716
• Report Number: 2015691-2024-01271
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)240628
• 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,Followup
• Report Date: 04/24/2024

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: 65166268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 04/23/2024
• Supplement Dates FDA Received: 03/11/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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