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

Model Number 20000ISM

Device Problem Activation Problem (4042)

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

Event Date 09/09/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.This mdr is linked to the mdr for the same patient and event under this number: 2015691-2023-16552.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.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where after the slda took place for the first device, a second device was then implanted to stabilize the first.The third device was intended to be implanted posterior-septal.The maximum gap measured there was around 12 mm.However, during the pulling of the first suture (lateral) the leaflet detached from the device.Because of clasp control of the septal leaflet still intact, a device retrieval was successfully performed.After the bailout, a flail was discovered in the posterior-septal commissure close to the annulus.According to the doctor (echo) the flail was probably a result of the device manipulations.A fourth device was then implanted, and the flail treated.Four devices were opened, with a total of three implanted.Due to the massive gap (12 mm) the regurgitation could only be reduced from 5+ to 4+.

Manufacturer Narrative

The complaint for loss of capture during the release was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.Available information suggests that patient conditions (the maximum leaflet gap measured there was around 12 mm) and procedural use (during the pulling of the first suture-lateral-the leaflet detached from the device and according to the doctor-echo, the flail was probably a result of the device manipulations) 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: 17887080
• MDR Text Key: 325120479
• Report Number: 2015691-2023-16602
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240718
• 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: 10/27/2023

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: 11035140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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 Sex: Male