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

Catalog Number CDS0706-XTW

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

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

Event Date 02/29/2024

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 that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and the difficult or delayed positioning associated with leaflet grasping and capture per the account is due to dense subvalvular structures, short, restricted leaflet, shadowing over clip and leaflet, and is therefore relate to patient conditions and procedural conditions.The reported device damaged by another device (dislodged) appears to be related to procedural conditions, and due to the second clip interacting with this first implanted clip, causing slda of this first implanted clip.Slda per the account is due to a combination of procedural conditions and patient conditions associated with the second clip interacting with this first implanted clip, causing slda of this first implanted clip, short posterior mitral leaflet (pml) and possible partial chord getting caught in the first clip (entrapment of device).A cause for entrapment of device, however, could not be determined.Image resolution poor is related to patient and procedural conditions as imaging was reported to be challenging due to patient anatomy.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 on (b)(6) 2024, a mitraclip procedure was performed to treat mitral regurgitation (mr) grade x.Imaging was challenging due to patient anatomy.A ntw was implanted first successfully, although insertion was difficult due to the restricted posterior leaflet.A second ntw clip was then attempted to be implanted.During maneuvering, this second clip interacted with the first clip eventually causing the first ntw clip to detach from the posterior leaflet (single leaflet device attachment (slda)).The second ntw was then placed to stabilize the slda.To further reduce mr, a third nt clip was implanted reducing mr to grade 2.There were no patient effects.The patient is reported to be stable.

• 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: 18954103
• MDR Text Key: 338303023
• Report Number: 2135147-2024-01308
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31102R2006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 100 KG