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

Catalog Number CDS0706-XT

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507)

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

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported this was an off-label mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 5 and a rotated heart.It was noted imaging was difficult throughout the procedure.One xt clip was inserted and successfully implanted.A second xt clip (31002a2082)was inserted and deployed on the tricuspid valve.To further reduce tr, a third xt clip (31002a2063) was inserted and advanced under the tricuspid valve.However, during placement of the third clip, it became caught in the chordae and resulted in the second implanted clip detaching from the septal leaflet and remaining attached to the posterior leaflet (single leaflet device attachment/slda).The third clip was able to be removed from the chordae and was deployed to stabilize the slda.However, after deployment, tissue damage was observed.To further stabilize the slda, an additional forth xt clip was implanted, reducing tr to a grade of 1.There was no clinically significant delay in the procedure.

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.H6: device code 1494 - indication for use (use in tricuspid valve).

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot 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 the reported image resolution poor was related to procedural conditions as imaging was difficult throughout the procedure.Slda appears to be related to procedural conditions, as during placement of the third clip, it became caught in the chordae and resulted in this second implanted clip detaching from the septal leaflet and remaining attached to the posterior leaflet (slda).The reported off-label use of the device was associated with the mitraclip device being used to treat tricuspid regurgitation (tr).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.

• 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: 18876243
• MDR Text Key: 337341785
• Report Number: 2135147-2024-01069
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)240930(10)31002A2082
• 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,Followup
• Report Date: 03/25/2024

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: CDS0706-XT
• Device Lot Number: 31002A2082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2023
• 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: CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 58 KG