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

Catalog Number CDS0702-XTW

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 1-2.An xtw (lot: 30605r1035) was chosen for implantation.During preparation while flushing the lock lever (pulling lock lever 3 times till the blue marker), the clip jumped open from 40° to 100°.Then after the flushing the clip functionality was tested.Here after doing the final arm angle test, the inversion of clip was to be tested.Here while trying to open the clip to invert the clip, the clip did not open.The arm positioner was again turned to neutral and the lock lever was retracted and the opening of the clip was tried once again.This time, the clip did not open at first instance but rather all of a sudden from closed position to around 90°.To ensure that the lock mechanism was working properly, final arm angle tests were done 2 more times and inversion was also done.During these maneuvers, the clip opened and closed properly.The system was also destressed by translating the device handle.The device was inserted and advanced to the valve.After grasping and after the final arm angle assessments, the result was very good (trace).After release of the clip, the clip slightly opened approximately 5 degrees (clip opened while locked (cowl)) and mr returned to baseline grade 1-2.There was no clinically significant delay.The procedure was abandoned, no intervention was performed.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.Based on available information, the reported difficult to open or close (clip jumping), associated with the clip jumping open during lock lever flush and clip inversion attempt, appears to be due to pre-procedural interactions (i.E., unintended curvature/ tension applied on the device) causing a sudden release of compressive stress off the actuator mandrel.Without the device to analyze, a cause of the reported difficult to open or close (clip open - difficult), associated with the difficulty to open the clip during prep, could not be determined.The cause of the reported unintended movement (clip open during efaa) and unintended movement (clip open while locked) during the procedure also could not be determined.The reported unchanged mr appears to be related to the unintended clip opening.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.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: 18627536
• MDR Text Key: 334357437
• Report Number: 2135147-2024-00470
• Device Sequence Number: 1
• Product Code: NKM
• 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: 03/05/2024

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: 30605R1035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Patient Outcome(s): Other