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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal ace procedure in mitral position.During procedure, a chord rupture was suspected during the grasping attempts of a second pascal ace.First ace was positioned in the medial part of a2/p2 with a 1/7 to 12/6 clocking.Clocking was very difficult, and it had to be corrected a lot of times after grasping because the ace had clocked against the clock during grasping.As reported, several maneuvers were performed to avoid chord entanglement such as elongated device under the leaflet, going back into the left atrium, and trying to approximate to the grasping zone from medial and central.After the first device was implanted, there was reduction from mitral regurgitation (mr) grade 4 with visible jet, but physician still wanted to keep the second ace to reduce jet and to improve v-wave.It was expected to have a significant reduction of mr after the second device.Second ace was positioned lateral, parallel and close to the first device, maximally 6mm beside the first.After several grasping attempts with the same issues regarding clocking, visible tension of the implant catheter (ic) was observed under fluoroscopy with a reduction to mr grade 2.However, the implanter wanted further improvement.After giving up the grasp, there were further issues getting into the right position clocking wise and trajectory wise when trying to narrow to the first ace.It was not possible to reproduce the mr grade 2 grasp although everything under fluoroscopy and echocardiography looked quite similar.The physician decided to leave and release the second ace there, as it was expected that the jet between the devices might reduce over time due to proliferation.V-wave pressure was reduced from 50mmhg to 25mmhg.After the case, the echocardiographer mentioned that the impossibility to reproduce the first result might be due to a ruptured chord but in the end the mediocre grasp with sufficient leaflet insertion that gave a reduction to mr grade 2 should have been kept.The patient had mixed etiology with a very broad jet.Anatomical challenges were significant calcification on posterior mitral leaflet (pml), probably calcified chords, chords in grasping zone and tethered pml.As reported, these challenges might have led to the event.Final mr report as 4+.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4) b2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.H6 clinical code: intraoperative cardiac valve injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : implanted.

Manufacturer Narrative

The reported chordae damaged during leaflet capture event does not allege a malfunction that could be related to an edwards manufacturing deficiency.In addition, a dhr review was completed, and this device passed all manufacturing and sterilization inspections.There are no nonconformances identified related to the complaint event.The allegation of chordae rupture as described in the complaint event was confirmed with other empirical evidence through account by the edwards clinical specialist present during the procedure.Based on the information available, patient anatomical conditions (significant calcification on posterior leaflet, probably calcified chords, tethered posterior leaflet) and procedural factors (chords in grasping zone) likely contributed to the 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: 18739862
• MDR Text Key: 335765201
• Report Number: 2015691-2024-01161
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Model Number: 20000ISM
• Device Lot Number: 11500047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Female