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

Catalog Number CDS0702-NT

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/20/2024

Event Type  malfunction  

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 identified no similar complaints reported from this lot.The investigation determined the reported poor image resolution was due to imaging equipment and the anatomy.The reported device damaged by another device (caused damage) appears to be related to the reported poor image resolution.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

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.

• 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: 18904564
• MDR Text Key: 337682640
• Report Number: 2135147-2024-01124
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2024
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 30515R1066
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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 Age: 76 YR
• Patient Sex: Male