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

Catalog Number CDS0702-XTW

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 3-4, prolapsed posterior mitral leaflet, and suboptimal height for puncture.A mitraclip xtw was inserted and advanced to the mitral valve, the m knob was applied, but without success.The system was moving in a different direction.It was noted that the clip delivery system (cds) was bending with the medial lateral (ml) knob, towards the roof of the atrium.Therefore, a decision to remove the clip was made.However, difficulties retracting the xtw into the steerable guide catheter occurred.It was noted that a weird angulation toward the plus and m side occurred.Troubleshooting was performed, and the clip was ultimately able to be retracted into the sgc.The xtw was removed together with the sgc from the patient.Another mitraclip xtw was implanted successfully.The procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported sleeve steering issues and difficult to remove cds were not confirmed via returned device analysis.Additionally, the gripper lever assembly tabs were returned broken and the gripper lever cap and gripper lever latch were returned detached.The clip introducer was also observed to be deformed.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 and the returned device analysis, the cause of the reported sleeve steering issues and difficult to remove cds were unable to be determined.The observed deformed clip introducer was likely a cascading event of troubleshooting the reported difficult to remove cds.The observed broken gripper lever assembly tabs, detached gripper lever cap, and gripper lever latch were likely due to post-procedural handling as no issues were reported.There is no indication of a product quality 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: 19111787
• MDR Text Key: 340339565
• Report Number: 2135147-2024-01699
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241126(10)31127R1111
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 05/23/2024

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: 31127R1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• 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