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

Catalog Number CDS0702-XTW

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is being filed due to recurrent mitral regurgitation, tissue injury, and worsening heart failure.Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(4).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with posterior leaflet prolapse.Two mitraclips were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, a follow-up echocardiogram was performed.Mr grade 2+ was noted.On (b)(6) 2024, elevated nt-probnp (heart failure lab) was noted.On (b)(6) 2024, eccentric, moderate mitral insufficiency at a1p1 was noted due to partial rupture of p1 likely related to clip 2 (cds0702 xtw, 10304r188) traction.Movement was noted due to the prolapse without any device deficiency/malfunction.Paradoxical aortic stenosis and severe functional tricuspid insufficiency (ti) were observed.Both the aortic stenosis and ti were deemed unrelated to the mitraclip device.The left ventricular ejection fraction was preserved.No treatment was provided.There was no device malfunction.The mitraclips remained stable and well seated.

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 recurrent mr and heart failure appear to be related to the reported tissue injury.The tissue injury appears to be related to the movement due to the prolapse.Mr, tissue injury, and heart failure are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no intervention performed to address the patient effects.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19213981
• MDR Text Key: 341400850
• Report Number: 2135147-2024-01909
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)220303(10)10304R188
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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 Expiration Date: 03/03/2022
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 10304R188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 47 KG