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

Model Number 20000ISA

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rupture (2208); Cusp Tear (2656)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal in mitral procedure where during the procedure, additional flail and leaflet perforation were noted.The md commented that leaflet integrity was at fault, and they were very surprised to see pascal cause any harm.They had grasping challenges and multiple capture attempts that concerned them for leaflet integrity.Baseline mr was severe, and ending mr was also severe since device was bailed out.After we tried to optimize it is difficult to say when it happened as we optimized multiple times it was noticed during an image sweep (cs did not actually see the flail and leaflet perforation happen).The flail or leaflet perforation was not treated.

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.H3 other text : not returned.

Manufacturer Narrative

The complaint for leaflet damaged while capturing was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.There was no allegation or indication a device malfunction contributed to this adverse event.Available information suggests that patient conditions (md commented that leaflet integrity was at fault) and procedure use (grasping challenges and multiple capture attempts that concerned them for leaflet integrity; optimized multiple times) 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: 18196311
• MDR Text Key: 328838184
• Report Number: 2015691-2023-17713
• Device Sequence Number: 1
• Product Code: NKM
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: 20000ISA
• Device Lot Number: 10809800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• 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