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

Model Number	20000GSA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional 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 is mdr 1 of 2 for this case.This one is on the guide sheath involved with the asd (atrial septal defect).
Event or Problem Description
Edwards received notification of a pascal in mitral position where 3 months after the index procedure, the patient died.The patient had received two p10 devices 3 months ago.The patient had left the procedure with a mild mr (mitral regurgitation) and a gradient of 5mmhg.Shortly after, the patient's gradient went up to 11mmhg and the mr increased to moderate/severe.There was no change to the implant position from post procedure per follow up imaging.The patient was subsequently hospitalized and treated for heart failure with diuretics.A large asd (atrial septal defect) with left to right shunting was also repaired about a month after the pascal with little change in patient status.Ultimately, the patient was put on comfort care and expired over the weekend from her heart failure.
Additional Manufacturer Narrative
The complaint for difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the dhr review.Available information suggests that patient conditions (worsening heart failure) may have contributed to the reported event.However, a definite root cause is unable to be determined.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: 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: 19721926
• Report Number: 2015691-2024-05268
• Device Sequence Number: 15522480
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)240910
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2024
• Device Model Number: 20000GSA
• Device Lot Number: 65281467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female