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

Catalog Number CDS0706-XTW

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/15/2024

Event Type  Injury  

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 other complaints reported from this lot.The investigation determined the reported slda appears to be a cascading effect of the reported device damaged by another device (dislodged).The report device damaged by anther device (dislodged) was due to interaction between the clips.The reported poor image resolution was due to imaging was challenging.The tissue injury (new chordal rupture) appears to be due to the slda.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, bi-leaflet prolapse, and pre-existing chordal rupture.It was noted imaging was challenging throughout the procedure.Three clips were inserted and successfully implanted.To further reduce mr, a fourth ntw clip (30118r1058) was inserted.However, while grasping with the fourth clip, it interacted with the second implanted xtw clip (31003a1020).The second implanted clip dislodged and detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).It was noted a new chordal rupture was observed.The fourth clip was unable to grasp the leaflets.Therefore, the clip was removed from the anatomy, and the procedure was discontinued.Mr remained at a grade of 4.There was no clinically significant delay in the procedure.

• 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 MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18572436
• MDR Text Key: 333617130
• Report Number: 2135147-2024-00346
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31003A1020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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: CLIP DELIVERY SYSTEM.; IMPLANTED MITRACLIP (X2).; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 86 KG