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

Model Number 20000ISMCL

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal in tricuspid position where during the patient's follow up tte at 30 days post procedure, it was noted that the posterior-septal device was not in its original position, it could not be located on tte.Patient is doing well and there are no plans for reintervention.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Other serious- even though there was no reintervention, there is a potential for reintervention in this case.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Not returned- still implanted.

Event Description

Upon completion of the image evaluation, there appeared to be a device embolization of the second ace device in 1-month follow-up tte (02/08/2023).There was an slda of the second ace device observed on the discharge tte (01/06/2023).The posterior tricuspid leaflet was no longer visualized attached to the second ace device and the ace device was mobile throughout the cardiac cycle.In the 1-month follow-up imaging the second ace device was no longer visualized in the right heart.Final residual tr appeared semi-quantitatively, 4 - massive.Could not confirm any evidence of device related issues or concerns.

Manufacturer Narrative

Image evaluation information was added.The following sections were updated:.

Manufacturer Narrative

The pascal training manual instructs the operator on position and deployment of the device, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the pascal system.Training includes patient screening (to ensure leaflet anatomy is suitable for the device), device preparation, procedural approach, device deployment, and imaging, through use of procedure specific training manuals and proctored procedures.Based on the imaging evaluation, an slda of the second ace device is observed on the discharge tte with the posterior tricuspid leaflet no longer visualized attached to the ace device and the device appearing mobile throughout the cardiac cycle.In subsequent review of the 1-month follow-up tte images provided, there appears to be a device embolization of the second ace device consistent with the reported event.The imaging evaluation identified procedural related issues (inadequate leaflet grasping, misinterpretation, and missing necessary maneuvers), and imaging related issues (no leaflet grasping clip recorded, and device or catheter shadow) as potential contributing factors to the device embolization, 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.There were no non-conformances identified related to the complaint event.

Manufacturer Narrative

Upon review of additional information received, this mdr and complaint will be voided since it is a duplicate of mfr report number 2015691-2023-10244 on complaint number 2023-00429-01.

• 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: 16399951
• MDR Text Key: 309787118
• Report Number: 2015691-2023-10945
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103211900
• UDI-Public: (01)00690103211900(17)230928
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2024

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 Expiration Date: 09/28/2023
• Device Model Number: 20000ISMCL
• Device Lot Number: 10116396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/22/2023; 04/03/2023; 01/02/2024
• Supplement Dates FDA Received: 02/28/2023; 04/03/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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 Sex: Male