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

Model Number 20000IS

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problems Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).B2: other serious- leaflet flail.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Not returned.

Event Description

Edwards received notification of a pascal precision procedure in mitral position where during the procedure, a leaflet flail was observed after several grasping attempts.The patient had a tethered posterior mitral leaflet (pml).During grasping pml the device clocked unintentionally and was in general difficult to grasp due to leaflet curling, after several grasping attempts in p3 a minor to mediocre flail was visible which could not be seen before.The heart frequency had been influenced with amiodoron in order to reduce heart rate until it was suitable for grasping.Heart rate was reduced from approx.120 to 60 bpm.After that a flail could be seen which most likely occurred during grasping attempts.After that it was decided to bailout the p10 device and switch to pascal ace.The flail in p3 could be caught with one ace and another ace was put beside to reduce remaining jet.A small jet without eccentric mainly lateral to the 2 ace devices remained.Another ace was not preferred due to remaining mitral valve area of only 1,7cm2 and also gradient of 2 with a heart rate of 60 under the influence of amiodoron.The physician wished for a better result because it was a young patient on the heart transplant list.Nevertheless, the procedure was beneficial for the patient and the flail that occurred could be fixed.Starting mr was grade 4 and post-procedural grade 2.

Manufacturer Narrative

The complaint for chordae damaged in attempt to capture leaflet was confirmed with other empirical evidence.No manufacturing non-conformities were found as a result of the complaint evaluation.Available information suggests that patient factors (heart frequency 120 and higher, a tethered posterior mitral leaflet (pml), leaflet curling), and procedural use (a flail could be seen, which most likely occurred during several grasping attempts) may have contributed to this adverse event.

Manufacturer Narrative

H6 device code updated to: patient device interaction problem.

• 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: 17666398
• MDR Text Key: 322468739
• Report Number: 2015691-2023-15630
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213317
• UDI-Public: (01)00690103213317(17)240508
• 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: 11/13/2023

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: 05/08/2024
• Device Model Number: 20000IS
• Device Lot Number: 10809750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 11/13/2023
• Supplement Dates FDA Received: 09/28/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 80 KG