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

Catalog Number CDS0702-NT

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report material deformation and mechanical jam.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4, restricted posterior leaflet, and a dilated ventricle.A mitraclip xtw was implanted without issues.To further reduce the mr, a mitraclip nt was advanced to the mitral valve, but upon clip deployment and while attempting to remove the lock line, resistance occurs until the line no longer moves.It was suspected that a knot had formed in the lock line.A decision to remove the clip was made.The clip was removed from the patient.A new mitraclip nt was selected for treatment and implanted without issues.The procedure was completed with two clips implanted.The mr was reduced to trace.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported material deformation (lock line) and mechanical jam (lock line ¿ inability) was confirmed via returned device analysis.The reported improper or incorrect procedure or method could not be replicated in a testing environment.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 complaints reported from this lot.Based on available information and the results of analysis, the reported and confirmed mechanical jam (lock line ¿ inability), associated with the inability to remove lock line, was due to a knot on the lock line.The material deformation (lock line knot) appears to be due to user proceeding to lock line removal without disentangling both ends of the lock line.The reported improper or incorrect procedure or method was associated with the user proceeding to lock line removal without separating both ends of the lock line.It should be noted that the mitraclip instructions for use (ifu) states under section 27.1 deployment step 1: lock line removal that ¿separate the ends of the lock line and remove the plastic cover from the lines so that no twists or knots are present.Warning: do not let line unravel freely.Do not remove lock line or plastic covers if line is bunched.Letting line unravel freely may result in knots in the line.Removing line if it is bunched may result in difficulty or inability to remove line due to knots or twists.¿ there is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: device code 2017 - failure to follow steps / instructions.

• 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: 17989790
• MDR Text Key: 326322008
• Report Number: 2135147-2023-04611
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 30125R1094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER