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

Model Number CDS0706-XT

Device Problems Break (1069); Off-Label Use (1494); Difficult to Open or Close (2921)

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

Event Date 04/27/2023

Event Type  malfunction  

Event Description

This is filed to report a gripper line break.It was reported that a mitraclip procedure was performed off-label to treat functional torrential tricuspid regurgitation (tr).Imaging was poor due to a previous mitral valve replacement.Two mitraclips were implanted successfully.During grasping with a third clip xt (30306r1077), one of the gripper lines was observed to be broke.Due to the broken gripper line, gripper actuation could not be performed, and the clip was removed and replaced.Four more mitraclips were implanted successfully.A seventh clip xtw (30208r2004) was then attempted to be implanted but the mandrel would not detach from the clip.Troubleshooting was performed and after approximately 10 minutes the clip was able to detach.However, after detachment from the delivery system the clip detached from the septal leaflet (single leaflet device attachment (slda)) and remained only attached to the posterior leaflet.An nt clip was then placed next to the slda clip for stabilization.A total of 8 clips were deployed, reducing tr to moderate.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 incidents reported from this lot.Based on available information, the reported poor image resolution was due to a previous mitral valve replacement.The reported difficult to open or close (gripper actuation issue) was due to a gripper line break.A cause of the reported gripper line break could not be determined.It should be noted that the mitraclip instructions for use states, ¿the mitraclip g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr>= 3+) due to primary abnormality of the mitral apparatus [degenerative mr]¿.The reported off-label use was associated with the use of mitraclip device for tricuspid valve repair.There is no indication of a product quality issue with respect to manufacture, design or labeling.Code 1494- indication for use; the additional mitraclip referenced in b5 is filed under a separate medwatch report number.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16963970
• MDR Text Key: 316046742
• Report Number: 2135147-2023-02215
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30306R1077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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
• Treatment: 2 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 86 KG