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

Catalog Number CDS0702-XTW

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/20/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 4 primary mitral regurgitation (mr), poor leaflet quality, and bi-leaflet mitral prolapse for a mitraclip procedure.The first xtw was implanted.The second xtw was implanted lateral to the first.The grasp was good and a lateral mr jet remined.The third nt clip was attempted to implant laterally to the xtw.During positioning, the second clip detached from the anterior leaflet.Visualizing the clip was noted to be difficult to the imaging equipment and the anatomy.A single leaflet device attachment occurred (slda).There was a possible interaction between the nt and the xtw, resulting in the slda.Both clips were close in fluoroscopy and it was noted to be difficult to confirm due to poor imaging quality.The leaflets were "barlow's-like" and of poor leaflet quality, which could have increased chances of slda.The nt was then removed from the patient.An xt was implanted in-between both xtws.This stabilized the movement of the slda clip.The patient maintained severe mr at the end of the procedure, but remained stable.There was a delay, but it was noted to be clinically significant.

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 slda appears to be related to the reported device damaged by another device (dislodged) and patient anatomy.The report device damaged by anther device (dislodged) appears to be due to the reported poor image resolution.The poor image resolution was due to imaging equipment and the anatomy.The unchanged mr appears to be due to the slda.Mr is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance as another clip was implanted to stabilize the movement of the slda clip.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 18904412
• MDR Text Key: 337669114
• Report Number: 2135147-2024-01123
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 30821R1013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 (X2); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male