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

Catalog Number CDS0705-NTW

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

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

Event Date 12/27/2023

Event Type  malfunction  

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 on (b)(6) 2023 to treat degenerative mitral regurgitation (mr) grade 4.The first clip (xtw lot: 30615r1073) was implanted medially without issue.A second clip (xtw lot: 30615r1074) was then implanted lateral to the first clip successfully.Gradient was 3mmhg.It was decided to implant a third clip (ntw lot: 30612r1026) to treat the lateral jet.When directing the device to the lateral region, difficulties were experienced in the response of the device for anterior/posterior medial lateral movements.The device did not respond to commands.When torque was performed on the steerable guide catheter, the device went to the side.The ntw was removed and a new insertion was carried out, checking the alignment of the blue line of the steerable valve with the blue line of the clip stem.The entire process was repeated to position the clip on the valve.When carrying out the maneuvers, the controls were again not responding.The ntw was removed again and inspected, where it was observed that the delivery sheath was curved even when at neutral.A replacement (ntw lot: 30612r1027) was then attempted to be implanted however, the gradient rose to 7mmhg so it was decided to not implant.The procedure ended with mr reduced to grade 2.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement associated with the cds moving in an unintended direction when torquing the sgc, the positioning failure associated with inability to curve/deflect the sleeve upon applying the knobs and the deformation due to compressive stress (bent shaft) were not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on information reviewed, the reported cds moving in an unintended direction when torquing the sgc, the positioning failure associated with inability to curve/deflect the sleeve upon applying the knobs and the bent shaft appear to be related to patient and procedural conditions as there was little height to position the device in the anatomy.The reported improper or incorrect procedure or method/user error is associated with the user removing the cds and re-inserting the same cds after removal.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: 18542738
• MDR Text Key: 333241614
• Report Number: 2135147-2024-00294
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288630
• UDI-Public: (01)08717648288630(17)240611(10)30612R1026
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/30/2024

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 Catalogue Number: CDS0705-NTW
• Device Lot Number: 30612R1026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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
• Patient Age: 92 YR
• Patient Sex: Male