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

Model Number	CDS0706-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information reviewed, the cause of the reported incomplete coaptation/ single leaflet device attachment (slda) appears to be related to a combination of morphology/pathology (friable tissue coupled with excessive mobility of the anterior leaflet and flail) and procedural factors due to visualization difficulty of the clip to confirm adequate leaflet insertion.The cause of the reported visualization difficulty could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances as additional clips were implanted to stabilize the slda clip.
Event or Problem Description
It was reported that on 18 february 2026, a patient presented with grade 4 mixed mitral regurgitation (mr), tethered posterior leaflet and a prolapsed flail anterior leaflet for a mitraclip procedure.During the procedure, first mitraclip was implanted and while second clip in the left atrium, it was determined that a single leaflet device attachment (slda) has occurred for the first clip and the clip was no longer attached to the posterior leaflet.Second clip was implanted on lateral side of the first clip.It was reported that there was no interaction between the first clip and second clip.It was believed that leaflet insertion was not adequate.Third clip was implanted to stabilize the first and second clip.Imaging was difficult.Per the physician, slda was due to pre-existing patient anatomy of both friable tissue coupled with excessive mobility of the anterior prolapsed, flailed leaflet.The final mr was grade 2.Were no adverse patient effects or clinically significant delays reported.

• 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: 24586321
• Report Number: 2135147-2026-01554
• Device Sequence Number: 5662826
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260806(10)50731A1115
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50731A1115
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female