MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 03/20/2024

Event Type  Injury  

Event Description

It was reported on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, a dilated left atrium, and a rotated heart.It was noted imaging was difficult throughout the procedure.An xtw clip was implanted, reducing mr to a grade of <1.On (b)(6) 2024, a pericardial effusion (pe) occurred.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported cardiac tamponade appears to be a cascading effect of pericardial effusion.However, a cause for the reported pericardial effusion cannot be determined.Pericardial effusion and cardiac tamponade are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case specific circumstances.The reported poor image resolution was due to the heart rotation.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported on 19mar2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, a dilated left atrium, and a rotated heart.It was noted imaging was difficult throughout the procedure.One xtw clip was implanted, reducing mr to a grade of <1.On (b)(6) 2024, the following day, a pericardial effusion (pe) occurred.Subsequent to the initially filed report, additional information was received stating on (b)(6) 2024, the patient experienced cardiac tamponade.To treat the pe, pericardiocentesis was performed.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19075547
• MDR Text Key: 339773024
• Report Number: 2135147-2024-01617
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241022(10)31024A1007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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 Catalogue Number: CDS0706-XTW
• Device Lot Number: 31024A1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male