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

Catalog Number CDS0702-XTW

Device Problem Leak/Splash (1354)

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

Event Date 02/14/2024

Event Type  malfunction  

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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.Na.

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4 and rotated heart.During preparation of an xtw clip (31012r2114), a leak was observed at the flush port on the delivery catheter (dc).Therefore, the clip delivery system (cds) was not used and was replaced.An xtw clip (31017r1086) was inserted and advanced to the mitral valve, but the clip became caught in chordae and the leaflets were caught on the grippers.Troubleshooting was performed and the clip was successfully freed from the chordae and leaflets.The clip able to be deployed on the mitral valve, but a chordal rupture was observed.To further reduce mr, an ntw clip (30620r1020) was inserted, and grasping attempts were performed.However, difficulties grasping and capturing the leaflets occurred resulting in an additional chordal rupture; therefore, the clip was removed and the procedure was discontinued.Mr remained at a grade of 4 and an impella heart pump was implanted.It was noted the patient effects resulted in a clinically significant delay in the procedure.

Manufacturer Narrative

All available information was investigated and the reported leak was confirmed via returned device analysis and observed the dc handle body seal to be damaged and not properly seated inside the slot of the handle body; therefore, exception (issue) 131124 was initiated on (b)(6)2024 to evaluate whether a product issue exists.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 leak appears to be related to the identified damaged handle body seal and seal not properly seated in the handle body.The damaged seal and seal not properly seated in the handle body appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

Event Description

N/a.

• 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: 18862519
• MDR Text Key: 337191622
• Report Number: 2135147-2024-01052
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241010(10)31012R2114
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/12/2024

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: CDS0702-XTW
• Device Lot Number: 31012R2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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