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

Catalog Number CDS0702-XT

Device Problem Inaccurate Information (4051)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The clip remains in the patient.The clip delivery system is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the mislabeling on the device.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One clip was implanted in the center of the mitral valve without issue.During unpacking of the second clip delivery system (cds) it was noted the device was labeled as a mitraclip g4 nt although the packaging was labeled as a mitraclip g4 xt.After inspection of the device, it was determined that it was an xt, therefore, the device was used in the procedure with no problem.The mr was reduced to 1.There was no clinically significant delay in the procedure and no adverse patient effects.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 complaints reported from this lot.The investigation determined the reported inaccurate information (incorrect labeling of the handle) appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12198050
• MDR Text Key: 262502674
• Report Number: 2024168-2021-06243
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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: 01/05/2022
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 10106U151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 09/12/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER