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

Model Number 20000ISM

Device Problem Separation Failure (2547)

Patient Problem Cardiac Perforation (2513)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The complaint for implant unable to be retrieved into sheath resulting in tissue damage during retrieval was confirmed with other empirical evidence via the testimony of the edwards on-site clinical specialist.No manufacturing non-conformities were identified from the event description or review the device history record.Available information suggests that procedural manipulations such as unintentionally retracting the guide sheath too early through the septum as well as potential patient factors may have contributed to the reported event.A definitive root cause cannot be determined as the device and imaging were not returned.H3 other text : implanted.

Event Description

Edwards received notification that during a pascal precision ace procedure in mitral position, the septum was damaged after bail-out of the pascal device.The first device was implanted with no reported difficulties.A second device was attempted but the regurgitation reduction did not change after several attempts and therefore the second implant was aborted.After bailout of the device, the septum was noted to be damaged.The guide sheath tip was in the septum during bail out and therefore the septum was damaged.There was no intervention during the index procedure to treat the damage and the patient was discharged.During a follow-up call with the clinical specialist, it was identified that the patient came back for an intervention to treat the septal damage with an occluder device.Additional details obtained during the call also indicated that the reason for the tissue damage was unknown and the bailout was performed correctly.The starting mr was severe and the final mr with one device implanted was moderate.

• 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: 18107308
• MDR Text Key: 327867607
• Report Number: 2015691-2023-17374
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240626
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/09/2023

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: 10969603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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