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

Catalog Number CDS0706-XT

Device Problems Entrapment of Device (1212); Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and restricted posterior leaflet.A mitraclip xtw was implanted.To further reduce mr, a mitraclip xt was inserted and advanced to the mitral valve and grasping attempts were performed.However, the xt became caught in the chordae.Troubleshooting was performed but was not successful.Multiple attempts were attempted to free the clip, but the clip could not be freed and was implanted where it was stuck with both clips in chordae.Difficulties visualizing the second clip during the procedure occurred.The procedure was completed with two clips implanted.The mr was reduced to a grade of 2-3.On the same day, post deployment, an echocardiogram was performed and revealed recurrent mr, and the previously implanted mitraclip xt had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).It was noted that the patient is receiving palliative care.

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 identified no manufacturing nonconformities 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 entrapment of device (clip becoming caught in anatomy) cannot be determined.The reported slda with the clip detaching from the posterior leaflet appears to be primarily related to patient conditions (restricted posterior leaflet) and additionally related to procedural conditions associated with the clip becoming caught in anatomy.Image resolution poor is related to procedural condition as slight difficulty with visualization was reported.Mitral valve insufficiency / regurgitation (mr) appears to be due to the slda.Mitral regurgitation is listed in the instructions for use 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.

• 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 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: 18639918
• MDR Text Key: 334536710
• Report Number: 2135147-2024-00488
• Device Sequence Number: 1
• Product Code: NKM
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30501R1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization