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

Model Number 20000ISM

Device Problem Activation Failure (3270)

Patient Problems Rupture (2208); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 10/31/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where a chordae rupture happened and also an slda.The leaflets were grasped with a good reduction but when the implant was released and after a couple of heartbeats, a septal chordae rupture happened, and the septal leaflet detached from the ace.The detached implant from posterior was stabilized with another pascal precision ace.No actions taken to solve the chordae rupture.As per medical opinion the rupture could be caused from the rheumatic disease the patient suffered from.The procedure was finished with a reduction of regurgitation from 4 to 2 and a gradient of 2.The patient left the or awake and under stable conditions.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(6).B2: other serious even though there was no reintervention, there is a potential for reintervention in this case due to the ruptured chord.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.H3 other text : implanted.

Manufacturer Narrative

The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) intra-procedure was confirmed with empirical evidence based on the report from the physician indicating the leaflet rupture could have been caused from the rheumatic disease the patient suffered from.Causes that may have contributed to inadequate leaflet capture resulting in slda could include but are not limited to- suboptimal trajectory and implant orientation, suboptimal alignment or positioning of catheters or the implant, inadequate leaflet optimization and grasping, misinterpretation of proper capture (e.G.Capturing chordae instead of leaflets), interaction between multiple implants, and/or interaction with previously implanted devices.Slda may also occur as the result of leaflet damage due to multiple capture attempts, difficulty to release implant, patient anatomy/pre-existing conditions.Imaging related issues may include incorrect echo view planes, failure to use 3d or color doppler, catheter shadowing, artifact, and misinterpretation of images.These events are not associated with device malfunctions or manufacturing nonconformances.Based on extensive complaint investigations, the root cause for slda events are most likely due to patient factors, procedural factors, imaging factors, or a combination of these factors.The pascal and pascal precision ifu and training materials provide adequate instructions on device implant, leaflet capture, and optimization prior to release.These events will continue to be monitored and complaints trending, and control limits are managed and assessed.

• 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: 18193348
• MDR Text Key: 328817678
• Report Number: 2015691-2023-17697
• 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: 12/06/2023

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: 11280349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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: 79 YR
• Patient Sex: Female