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

Model Number 20000ISM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Rupture (2208); Cusp Tear (2656); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/01/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where the anterior leaflet detached.The septal leaflet was tethered in anterior/septal commissure until central.The doctor tried to grasp in this area but the anterior as well as septal leaflet did not look like it was all the way in.The implanter decided to release it and after the suture release, the device jumped to septal, and the anterior leaflet was detached.The doctor was concerned about leaving the device attached only to one leaflet because it could embolize.The clinical specialist (cs) explained the bail out technique and so, the device and guide sheath (gs) were retrieved.Once done a piece of leaflet was stuck in the pascal device.But, the tricuspid insufficiency (ti) was not worse than before (ti was 5 before and after the procedure) but there were ruptured chords that flailed up into the ra.A second gs and a pascal was prepared according to ifu.The attempt to grasp the septal leaflet again was not successful due to tethering of septal leaflet and echo quality.The doctors then decided to bail out the second device without being able to treat the ti.As per medical opinion, the doctor had a leaflet detachment before but never the situation that the implant catheter jumped towards septal without seeing any tension on catheter before.

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.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.

Manufacturer Narrative

The complaint for loss of capture during the release was confirmed with other empirical evidence.No manufacturing non-conformities were found in the returned sample.Available information suggests that patient conditions (large gap between atl and stl) and procedural factors (maneuvers applied with the implant) may have contributed to the reported 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: 17187837
• MDR Text Key: 317719021
• Report Number: 2015691-2023-14153
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240504
• 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: 08/31/2023

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 Expiration Date: 05/04/2024
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Device Lot Number: 10777014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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 Sex: Male