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

Catalog Number CDS0705-NT

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4, an enlarged atrium, and a calcified posterior leaflet.One nt clip was implanted, reducing mr to a grade of 1.Roughly seven months post procedure, the patient returned to the hospital for a follow up.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to return.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and the reported slda appears to be related to patient conditions as evaluation of the posterior leaflet was reported to be difficult due to calcification in the grasping area.It was confirmed that there were no difficulties visualizing the clip during the procedure.Mitral valve insufficiency/ regurgitation (mr) appears to be due to the slda.Mitral regurgitation is listed as a known possible complication associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported on 24aug2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4, an enlarged atrium, and a calcified posterior leaflet.One nt clip (30324r1045) was implanted, reducing mr to a grade of 1.Roughly seven months post procedure, the patient returned to the hospital for a follow up.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 3.Subsequent to the initially filed report, additional information was received stating on (b)(6) 2024, an additional mitraclip procedure was performed.To stabilize the slda, an additional nt clip (30728r1054) was attempted to be deployed.However, the clip was unable to advance to the mitral valve due to the anatomy of a narrow left atrium.Therefore, the clip was removed, and the procedure was discontinued.Mr remained at a grade of 3.

• 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: 19153096
• MDR Text Key: 340717978
• Report Number: 2135147-2024-01786
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288616
• UDI-Public: (01)08717648288616(17)240322(10)30324R1045
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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: 03/22/2024
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 30324R1045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Race: Asian