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

Catalog Number CDS0706-NTW

Device Problems Material Deformation (2976); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.A mitraclip ntw was inserted and placed on the mitral valve.While attempting to deploy the clip and prior to removing the lock line, a knot was observed on the lock line.The lock line was removed roughly 1 to inches when resistance was encountered.In order to deploy the clip, the lock line was pulled with forceps in an attempt to unlock the clip.A pop was heard/felt and the line was then able to be pulled through.The clip was successfully deployed, reducing the mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis was unable to confirm the reported difficulty to remove the lock line; however, it was observed that the lock line was broken and the broken piece was unable to be removed from the device and was determined to be related to the knot identified on the lock line (material deformation).Therefore, the reported material deformation associated with a lock line knot was confirmed.There was also a portion of the lock line that was received separately from the device.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information reviewed, while the reported difficulty / observed inability removing the lock line appears to be the result of the knot (material deformation), a cause for how the knot formed could not be determined.The reported noise appears to be a symptom of the observed lock line break.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 18322951
• MDR Text Key: 330428523
• Report Number: 2135147-2023-05500
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30510A1092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention