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

Catalog Number CDS0706-NTW

Device Problems Difficult or Delayed Positioning (1157); Device Damaged by Another Device (2915)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.It was noted that imaging was challenging due to the patient's anatomy and the imaging equipment.The procedure was carried out as per instructions for use (ifu).The first clip was deployed and well seated.The second clip was planned to implant lateral to the first.The second clip became entangled in the chordae.After troubleshooting maneuvers, the clip became free but inadvertently swung into the first clip.This resulted in a single leaflet device attachment (slda) of the first clip.The clip was detached from the posterior leaflet.There was no leaflet injury observed.The second clip was replaced with a new device to stabilize the slda and reduce the mr.The mr was reduced to grade 2-3.There were no adverse patient sequelae or clinically significant delay.

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 difficult or delayed positioning associated with clip caught on chordae appears to be related to user technique.The reported device damaged by another device (caused damage) was due to troubleshooting maneuvers to remove the clip from the chordae and the reported poor image resolution was due to patient's anatomy and the imaging equipment.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 MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18913002
• MDR Text Key: 337771360
• Report Number: 2135147-2024-01133
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: 03/15/2024

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 Catalogue Number: CDS0706-NTW
• Device Lot Number: 30724A2029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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; STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Female