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

Catalog Number CDS0706-XT

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that on an unknown date, a mitraclip procedure was performed to treat mitral regurgitation and flail.On an unknown date, at a one month follow up, an echocardiogram was performed and revealed recurrent mitral regurgitation.It was noted that the physician was concerned that the clip had a side bite or a chord in the grasp.

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 on an unknown date, a mitraclip procedure was performed to treat mitral regurgitation and flail.On an unknown date, at a one month follow up, an echocardiogram was performed and revealed recurrent mitral regurgitation.It was noted that the physician was concerned that the clip had a side bite or a chord in the grasp.Subsequent to the previously filed report, additional information was received: it was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ and flail.A mitraclip xt was inserted, and grasping was performed.However, difficulties visualizing the clip during the procedure occurred.The clip was implanted.However, following deployment, the clip rotated.In the physician¿s opinion, this was likely due chordae being grasped with the leaflets.The procedure was completed with one clip implanted, reducing the mr to a grade of 1+.On (b)(6) 2024, the patient returned for a one month follow up.An echocardiogram was performed and revealed that the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing the mr to increase to a grade of 4+.

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.The investigation was unable to determine a cause for the reported entrapment of device (chordae being grasped with the leaflets).The poor image resolution was associated with very challenging imaging.The reported migration (partial clip movement) and subsequent slda appear to be cascading effects of the entrapment of device.The reported mr appears to be due to the slda.Mr 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 additional treatment/intervention was provided.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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 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: 19087471
• MDR Text Key: 339911150
• Report Number: 2135147-2024-01637
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)240410(10)30412R1011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30412R1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2023
• 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
• Patient Outcome(s): Other