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

Catalog Number CDS0702-XTW

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/20/2024

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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade 3 and thin leaflets.A mitraclip ntw was inserted and deployed.However, during deployment, the anterior mitral leaflet (aml) was observed to be injured.It was noted that the clip remained stable on both leaflets.A mitraclip xtw was then inserted, positioned medially to the first implanted clip, and grasping attempts were performed.However, difficulties grasping and capturing the leaflets occurred.The clip could no longer be pulled back into the atrium as it was caught in chordae.Troubleshooting was performed, but the clip was unable to be removed.The clip was deployed, but it was only deployed on the anterior leaflet.No additional clips were implanted and mr increased to a grade of 4.There was no clinically significant delay in the procedure.

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.The investigation determined the reported difficulty grasping and difficulty capturing the leaflets appear to be related to patient morphology/pathology (thin leaflets) and procedural condition (injured anterior mitral leaflet).The reported entrapment of device (clip caught on chordae) appears to be due to troubleshooting maneuvers of the difficulties grasping and capturing.The reported worsening mr appears to be related to the tissue injury in conjunction with the reported entrapment of device.Mr is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The patient effect of foreign body in patient was due to the entrapment of device as the clip was deployed only on the anterior leaflet with the chordae.The reported serious injury/illness/impairment was a result of case specific circumstance as no intervention have been performed to address the reported issue.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 18904049
• MDR Text Key: 337664261
• Report Number: 2135147-2024-01121
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241009(10)31011R1102
• 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,Followup
• Report Date: 04/12/2024

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: 31011R1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other