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 02/13/2024

Event Type  malfunction  

Event Description

It was reported that a combined mitraclip procedure was performed to treat mitral and tricuspid regurgitation.The steerable guide catheter (sgc) was advanced through the septum to treat functional mitral regurgitation (mr) with grade of 4.One clip was implanted, reducing mr to grade 1-2.The sgc was then retracted to the right atrium to treat mixed tricuspid regurgitation (tr) with grade of 4.The tricuspid valve had two posterior leaflets and a pacemaker lead between the septal and posterior leaflets near the commissure.Visualization was noted to be difficult due to patient¿s anatomy.Two mitraclip were implanted.After deployment of the second clip, the clip detached from the posterior leaflet (single leaflet device attachment (slda)).Final tr was at grade 1-2.There was no clinically significant delay in the procedure and no adverse patient sequelae.

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.Based on available information, a cause of the reported incomplete coaptation (slda, single leaflet device attachment), associated with clip detachment from the posterior leaflet, could not be determined.The reported image resolution poor was due to challenging patient anatomy.The reported off-label use was associated with using the mitraclip device for tricuspid valve repair.There is no indication of a product quality 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: 18832267
• MDR Text Key: 336849696
• Report Number: 2135147-2024-00979
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: 05415067037404
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 31002A2065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 63 KG