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 03/14/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a patient presented with grade 4+ degenerative mitral regurgitation (mr) and a prolapsed posterior leaflet for a mitraclip procedure.Two mitraclips were implanted and the mr was reduced to grade 2.On 14mar2024, the patient returned with shortness of breath and worsened grade 4+ mr located in the same central position of the first clip that was implanted on (b)(6) 2024 (cds0702-xtw-30822r2068).It was noted that a single leaflet device attachment (slda) occurred, and the clip was detached from the posterior leaflet segment 2 (p2) and firmly attached to the anterior leaflet segment 2 (a2).It was decided to implant an xt clip to stabilize the detached clip, and to try to reduce the severe mr.The xt clip was positioned in the a2-p2 position with an effective and stable grasp, lateral to the detached clip.The clip was deployed.The procedure was successfully completed.The procedure ended with a final grade 1-2 mr.There were no adverse patient sequelae or clinically significant delay.

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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, the cause of the reported slda was unable to be determined.The reported recurrent mr was a cascading event of the reported slda.The reported dyspnea was a cascading event of the reported recurrent mr.The reported patient effects of mitral regurgitation and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality 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: 19051441
• MDR Text Key: 339492333
• Report Number: 2135147-2024-01566
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)240820(10)30822R2068
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30822R2068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2023
• 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
• Treatment: MITRACLIP
• Patient Outcome(s): Required Intervention; Hospitalization