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); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  Injury  

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 reported unintended movement of the clip and entrapment of device (clip becoming caught in chordae/anatomy) resulting in slda associated with the clip detaching from the posterior leaflet cannot be determined.Unexpected medical intervention was 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 that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and flail.A mitraclip ntw was implanted without issues, reducing the mr to a grade of 2.However, residual mr was noted.To further reduce mr, a mitraclip xt was inserted and advanced to the left ventricle, but the clip arms had rotated from a 12 to 6 orientation to a 3 to 8 position.The clip arms were inverted and an attempt to bring the clip to the left atrium (la) was made.However, the clip became caught in chordae.Troubleshooting was performed, but the clip was not able to become free from the chordae.Therefore, the clip was deployed where it was stuck, attached to both leaflets, with chordae.It was noted that the posterior mitral leaflet insertion was questionable.Approximately 5 minutes post deployment, the clip detached from the posterior mitral leaflet and remained attached to the anterior mitral leaflet (single leaflet device attachment/slda).The procedure was completed with two clips implanted, reducing the mr to a grade of 1.It was noted that the clip remained stable on the leaflets.On the next day, the clip was confirmed stable on the leaflets.There was no clinically significant delay in the procedure.

• 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: 18725373
• MDR Text Key: 335717369
• Report Number: 2135147-2024-00722
• 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
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30829R1062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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