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

Model Number 20000GS

Device Problems Device Difficult to Setup or Prepare (1487); Misassembly by Users (3133)

Patient Problems Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Even though there was no serious injury involved, an intervention was performed (aspiration).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where during the procedure, air bubbles were noted.After insertion of the implant system (is) into the guide sheath (gs) and retracting the loader, the first operator spotted air bubbles coming out of the gs tip and into the left atrium (la), and so immediately started aspirating.Syringe was on the flush port when bubbles were observed.The pressure monitoring line was attached by 2nd operator prior to aspirating the gs but the clinical specialist stressed the importance to attach the pressure line only when the device was already inserted into the la and closed.The physician moved the gs to the bubbles and aspirated (near aortic root).The first operator also noted that the ring on the pressure line was filling with blood and suspected that the ring might not be sealed enough and could also be the source of the air.The physician aspirated 2 full syringes to be safe and air bubbles were not visible on echo after 3-4 minutes.As no more air was visible, the first operator decided to proceed with the same device, flushed the gs with saline and it did not give blood back.Mitral regurgitation (mr) was treated with the implantation of one device and reduced from grade 3 to grade 1.There were never any signs for the patient being negatively affected by the issue (no st-elevation) and the patient woke up after the procedure without any issues and was noted as to be doing fine.

Manufacturer Narrative

The following sections have been added/updated/corrected: b4, d4, g3, g6, h2, h3, h4, h6 and h10.The complaint for saline drip connected prior to aspiration-air introduced into vasculature was confirmed with objective evidence via clinical specialist observation, confirmation of air on imaging evaluation, and replication of the event via functional testing.No manufacturing non-conformities were found in the returned sample.Available information suggests that use error contributed to the event via connection of pressure monitoring prior to aspirating the gs.

• 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: 17167495
• MDR Text Key: 317638931
• Report Number: 2015691-2023-14047
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240320
• 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: 08/24/2023

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 Expiration Date: 03/20/2024
• Device Model Number: 20000GS
• Device Lot Number: 64969576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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