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

Catalog Number CDS0705-NTW

Device Problems Premature Activation (1484); Off-Label Use (1494); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), dilated left atrium, and torrential functional tricuspid regurgitation (tr) for a concomitant mitraclip and triclip procedure.The second clip, an ntw mitraclip, was prepared and delivered to the left atrium through a triclip steerable guide catheter (tsgc).Straddle position was obtained and clip delivery system (cds) was prepared to apply m knob to flex the clip towards mitral valve.From fluoroscopy, the clip appeared misaligned with the shaft of cds (with an angle of around 10 degrees).The clip was carefully withdrawn through the guide and checked outside patient's body.It appeared to be loosely attached to the shaft tip.The clip was still connected to all visible components of the delivery catheter.Another ntw was implanted at anterior 2 and posterior 2 leaflets (a2/p2), followed by an nt implanted lateral to first clip.Mr was successfully reduced from grade 4 to grade 1.Triclip procedure followed with successful implantation of a triclip xtw at mid-to-central anterior-septal leaflets (a-s).The tr was reduced from massive to moderate.There were no adverse patient effects.There was a delay, but there was no patient harm.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18447090
• MDR Text Key: 332147815
• Report Number: 2135147-2024-00071
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30619R1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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: TRICLIP STEERABLE GUIDE CATHETER