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

Model Number	CDS0706-XTW
Medical Device Problem Codes	Positioning Failure (1158); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with degenerative mitral regurgitation (mr), myxomatous posterior leaflet 2, wide prolapse of more than 15mm and flail gap of 10mm for a mitraclip procedure.During the procedure, first mitraclip was implanted.During implantation of second mitraclip, first grasp was difficult and there was interaction with chords.Second mitraclip was placed on the central side of anterior and posterior leaflet 2 (a2p2), as there was no change in the mr, the clip was moved to the medial side of the first clip and there was no significant mr reduction.It was decided to move closer to the first clip, grasping was obtained without significant mr reduction and increase in the gradient to above 6 mmhg.It was decided to invert the clip and come into the left atrium.Clip was closed and was moved lateral to the first clip.First clip appeared to be stable from the initial release.Paralax was removed from the second clip to match the first clip.Second clip was opened and it was determined that the clip interacted with the posterior mitral leaflet and the flail segment.Clip was inverted and retracted.Clip was initially thought to be freed from the interaction with the leaflet.On closing the clip, it was observed that there was motion in the first clip.On echo, it was determined that the first clip had single leaflet device attachment (slda) has occurred and clip was no longer attached to the posterior leaflet.Second clip was inverted and retracted into the left atrium released the interaction and the clip was removed from the patient.Procedure was discontinued.The final mr was grade 4.There were no adverse patient effects or clinically significant delays reported.
Additional 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 the reported device causing damage, positioning failure, or poor imaging.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported device causing damage appears to be related to procedural conditions (interaction with posterior leaflet caused incomplete coaptation with an implanted clip).The reported positioning failure appears to be related to a combination of challenging patient anatomy and procedural conditions (poor imaging, remaining prolapse, flail gap).The reported poor imaging appears to be related to procedural conditions (shadowing from sgc).There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Common Device Name: 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: 24652155
• Report Number: 2135147-2026-01794
• Device Sequence Number: 10207417
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260807(10)50808A1116
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50808A1116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEERABLE GUIDE CATHETER.
• Patient Age: 84 YR
• Patient Sex: Female