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

Catalog Number CDS0706-NT

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

This is filed to report a gripper actuation issue and a broken gripper line.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was inserted and successfully implanted.To further reduce mr, a second nt clip was inserted, however, the posterior gripper was not working properly.It was observed the gripper line was broken.Therefore, the clip was removed, and the procedure was discontinued.Mr reduced to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Manufacturer Narrative

All available information was investigated, and the reported single gripper actuation issue and broken gripper line were confirmed via returned device analysis.The reported difficult positioning (anatomy) and improper or incorrect method or procedure 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, the cause of the reported broken gripper line and difficult positioning (anatomy) were unable to be determined.The reported single gripper actuation issue was a cascading event of the reported broken gripper line.The reported improper or incorrect procedure or method was associated with the user having the grippers lowered while closing the clip.It should be noted that the mitraclip instructions for use (ifu) states ¿raise the gripper(s), unlock the clip, and invert the clip arms.Lock the clip, fully close the clip arms, and lower the gripper(s).¿ 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.

Event Description

Subsequent to the initially filed report, additional information was received stating challenging anatomy included thick leaflets and dense chordae.Also, when the second nt clip was inserted, it became caught in the chordae and was able to be removed.

• 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 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: 17882352
• MDR Text Key: 325079228
• Report Number: 2135147-2023-04357
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 30322R1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 89 YR
• Patient Sex: Female