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

Catalog Number CDS0702-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a patient presented with grade 4 secondary mitral regurgitation for a mitraclip procedure.Two xtw clips were implanted, one central and the other centro lateral.The mr was reduced to grade 1.On (b)(6) 2023, the patient returned symptomatic.The patient was symptomatic with dyspnea and recurrent grade 4 mr.A transesophageal echocardiogram (tee) was performed.It was noted that the centro lateral xtw was detached from the anterior leaflet.A single leaflet device attachment (slda) occurred.On (b)(6) 2023 a second clip intervention was performed.One additional clip was implanted and the mr was reduced from grade 4 to 1.There were no adverse patient sequelae.No additional information was provided.

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 a cause for the reported slda associated with the clip detaching from the anterior leaflet cannot be determined.Mitral valve insufficiency/ regurgitation (mr) resulting in dyspnea appears to be due to the slda.Dyspnea and mitral regurgitation are known possible complications 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.

• 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: 18415290
• MDR Text Key: 331580006
• Report Number: 2135147-2023-05728
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20802R1081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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: MITRACLIP.
• Patient Outcome(s): Required Intervention; Hospitalization