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

Catalog Number CDS0705-XT

Device Problems Difficult or Delayed Activation (2577); Material Deformation (2976)

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

Event Date 03/05/2024

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 functional mitral regurgitation (mr) with a grade of 4, restricted posterior leaflet, and bi-leaflet tethering.A mitraclip xtw was implanted without issues.A mitraclip xt was then inserted and placed on the mitral valve, lateral to the xtw.While attempting to deploy the clip, difficulties unwinding the lock line (ll) occurred.The lock cap was removed, the rubber o ring came off, and an attempt to unwind the lock line was made.However, the lock line was tightly wrapped around the lock mechanism.A lot of time was spent to slowly untie the lock line, and kelly forceps was used to hold the line away.After about 5-10 minutes, a knot was observed in the lock line.To deploy the clip, the ll had to be cut, and the ll was able to be deployed.The procedure was completed with two clips implanted, reducing the mr to a grade of 1.There was no clinically significant delay in the procedure.

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 was unable to determine a cause for the reported difficult or delayed activation due to inability to unwrap the lock line.The reported knot on the lock line appears to occur during maneuvers to unwrap of the line.The reported unexpected medical intervention was a result of case specific circumstance as forceps was used to hold the line and the line was cut to deploy the clip.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 18983675
• MDR Text Key: 338659576
• Report Number: 2135147-2024-01354
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288623
• UDI-Public: (01)08717648288623(17)240801(10)30803R1088
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/17/2024

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 Catalogue Number: CDS0705-XT
• Device Lot Number: 30803R1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White