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

Model Number 20000ISM

Device Problem Activation Problem (4042)

Patient Problems Cusp Tear (2656); Mitral Valve Insufficiency/ Regurgitation (4451); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(6).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 precision ace procedure in mitral position where during the procedure, there was a loss of leaflet capture of the anterior mitral leaflet (aml).As reported, device functions were normal and unremarkable during device preparation, steering down, grasping and closing maneuvers.No malfunction was detected.Several attempts to get a good grasp were necessary in this case but due to very dense chords at the posterior mitral leaflet (pml) it was very difficult to get a good grasp with a good reduction of mr.It was very difficult not to grasp any chords.The final grasp seemed to be good after optimizing first the aml and second the pml.Many previous grasps showed a high gradient, but the final grasp achieved a good reduction with a gradient of 5mmhg.After a final assessment, the release was initiated.Due to the issues on the pml it was decided to pull of the suture of the pml clasp first and everything was stable.While removing the suture of the aml clasp, a slda on the aml occurred after about half of the suture was pulled out.More resistance was noticed when pulling the aml suture compared to the pml suture.Different trouble shooting maneuvers were performed to bailout the device.First, the physician tried to bailout with the rolling technique, but it did not work.It was not possible to get the leaflet free.After some time, the physician got additionally stuck with the elongated device in the chordal apparatus below the pml in the ventricle as it was not possible to close the device anymore.Therefore, the guide sheath (gs) clasps capture method was tried, however the clasp could not be caught with the gs due to a not closed device.After some time of manipulation and different movements, it was possible to bailout without suture control and the decision was to finish the procedure.The mitral regurgitation (mr) had worsened, likely due to a possible damage in the pml caused by the troubleshooting maneuvers.As reported, patient was stable after the procedure and under consideration for valve replacement.

Manufacturer Narrative

The complaint for loss of capture during the release was confirmed with objective evidence via imaging evaluation.No manufacturing non-conformities were confirmed to have contributed to the event via product evaluation or imaging evaluation.Challenges during the procedure, pre-release loss of leaflet, and high removal force all may have contributed to the reported event.However, a definite root cause is unable to be determined.

Manufacturer Narrative

H6 clinical code: intraoperative cardiac valve injury.

Event Description

Additional information received stated that the patient already went through valve replacement and is stable.After internal imaging review, there appears to be loss of leaflet capture of the anterior mitral leaflet during release of the pascal ace device on the procedural tee.The pascal ace device is successfully bailed out.However, subsequently, there appears to be a new p2 flail segment and posterior mitral leaflet perforation.

• 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: 18686419
• MDR Text Key: 335139019
• Report Number: 2015691-2024-00948
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240801
• 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,Followup
• Report Date: 04/11/2024

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: 11106039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 04/10/2024
• Supplement Dates FDA Received: 03/21/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female