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

Model Number 20000GS

Device Problem Difficult to Insert (1316)

Patient Problems Hypovolemic Shock (1917); Perforation of Vessels (2135)

Event Date 02/01/2024

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.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where during procedure, while inserting the guide sheath (gs), the operator struggled with tortuosity of vena iliaca communis.With a few tries, the patient started to lose blood pressure rapidly.After actions of anesthesia team, it was decided to flush contrast into the vein to check if there are any bleedings.The contrast film showed massive rupture in between vena iliaca communis and vena cava.Physician pulled out the gs and put in a special balloon to stop the bleeding.After consulting with vascular surgeons and ic, patient was taken immediately to or for emergency surgery.The surgery was 7 hours long, a very complex and risky procedure.In discussion after the case, the probable cause of rupture could be to floppy guide wire for this kind of anatomy (standard amplatzer extra stiff).The patient was going to be re-intervened in the near future.

Manufacturer Narrative

The following sections were updated/corrected/added: h6 and h10.The complaint for difficult to insert device into patient resulting in tissue damage was confirmed with other empirical evidence.As there were no images provided for this adverse event, an imaging evaluation could not be performed.No manufacturing non-conformities were identified from the investigation.Available information suggests that patient conditions (while inserting the guide sheath (gs), the operator struggled with tortuosity of vena iliaca communis), and procedural use (contrast film showed massive rupture in between vena iliaca communis and vena cava, and probable cause of rupture could be to floppy guide wire for this kind of anatomy) (standard amplatzer extra stiff) likely contributed to the adverse event.

• 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: 18791885
• MDR Text Key: 336367381
• Report Number: 2015691-2024-01391
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240823
• 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: 03/04/2024

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 Model Number: 20000GS
• Device Lot Number: 65270948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/02/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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 Sex: Female