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

Model Number 20000ISMCL

Device Problems Activation Failure (3270); Migration (4003)

Patient Problems Foreign Body Embolism (4439); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 01/06/2023

Event Type  Injury  

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.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, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.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 in tricuspid position where 24 hours after a successfully procedure of implanting 2 pascal ace devices (1 anterior-septal ace and 1posterior-septal ace), during the patients discharge tte, there was evidence noted of an slda off the posterior leaflet.The pre-procedure tr was torrential.After successfully implanting 2 ace devices, the final post procedural residual tr was graded mild.Post-slda tr grade was unknown.The patient is doing very well and there are currently no plans of reintervention.Additional information after completion of image evaluation stated that there was severe residual tr and the second (most posterior) ace device appeared mobile throughout the cardiac cycle without definite evidence of an slda in the discharge tte on (b)(6) 2023.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Despite the most posterior implant appearing mobile throughout the cardiac cycle, the presence of an slda as described in the complaint event was unable to be confirmed through imaging evaluation (ie).Potential contributing factors to the sldas are procedural related issues including inadequate leaflet grasping, missing necessary maneuvers, or misinterpretation, and imaging issues including no recordings of the leaflet grasping clip, improper presets, and inaccurate view planes based on the ie.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.There are no nonconformance's identified related to the complaint event.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for implant detaches from both leaflets into vasculature (post procedure) was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.The alleged implant embolization was confirmed via review of the 1-month follow-up tte images showing the device no longer in the right heart.Available information suggests that procedural relates issues and imaging related issues may have contributed to the reported event, however a definite root cause is unable to be determined.

Event Description

Further information received stated that 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.Additional information received from clinical safety also stated that the patient presented to the ed on (b)(6) 2023 for worsening diffuse edema from legs up through the abdomen.He was treated with bumex 2 mg and remained in ed observation overnight.The next day he was treated with metolazone 5 mg and bumex 2 mg.He returned to near-baseline edema and was sent home.

Manufacturer Narrative

Upon review of additional information received, this mdr is linked/related to mfr report number 2015691-2023-10945-1 on complaint number (b)(4).Due to (b)(4) with mfr report number 2015691-2023-10945-1 being a duplicate of this complaint, that complaint and mdr will be voided, and this mdr will remain.

• 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: 16188613
• MDR Text Key: 307560188
• Report Number: 2015691-2023-10244
• Device Sequence Number: 1
• Product Code: NKM
• 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: Study,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2024

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: 09/27/2023
• Device Model Number: 20000ISMCL
• Device Lot Number: 10116429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 01/02/2024; Not provided
• Supplement Dates FDA Received: 02/27/2023; 01/26/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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 Outcome(s): Other
• Patient Sex: Male