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

Model Number 20000ISM

Device Problem Use of Device Problem (1670)

Patient Problem Cusp Tear (2656)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).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.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where during the procedure several grasps were attempted centrally and more medial, but none of them could significantly reduce the jet.The physician did some manipulation on the guide with the clasps were still down and implant was closed.After the physician was told that the device was still closed, the clasps were put up and got in capture ready again.The echo physician said that at the moment the device was in capture ready position, there was some released tension and some smaller substantial lesion/defect on the leaflet was noticed.The defect happened at the end of several grasping attempts with some issue such as tethered pml and pml was short, but tendency was over 7mm length.No grasping was so good that there was a visible reduction.The team was not sure if going for a two-device strategy in expectation to have the second ace reducing the mr from mr4 to mr 0-1 would be the right thing.The device was bailed out because the doctors wanted to discuss the case in the team again and with the patient and tell the patient that it is possible that teer will probably be challenging and could end with a minor to mediocre reduction.The age of the patient made them also think if teer or surgery is the right option.The substantial defect did not play a big role in that decision and had no measurable influence on the mitral regurgitation.

Event Description

Additional information received stated that the patient went through surgery, and it was successful.

Manufacturer Narrative

The complaint for implant repositioned while clasps still on leaflets resulting in tissue damage was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.As there were no images provided for this adverse event, an imaging evaluation could not be performed.Available information suggests that procedural user error (the physician did some manipulation on the guide with the clasps still down and implant closed) likely contributed to the adverse event.

Manufacturer Narrative

H6 impact code was updated to: additional surgery.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h10.H6 impact code was updated to: device explantation.

• 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: 18791520
• MDR Text Key: 336395883
• Report Number: 2015691-2024-01388
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241206
• 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,Followup,Followup
• Report Date: 04/05/2024

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: 11526625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 03/28/2024; 04/02/2024; 04/05/2024
• Supplement Dates FDA Received: 03/25/2024; 03/28/2024; 04/03/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Female