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

Model Number	CDS0706-XTW
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Foreign Body In Patient (2687)
Date of Event	01/20/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (mr), friable leaflets, thick and flail posterior leaflet and cancer for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.The mr was reduced to grade 1+ post procedure.Post procedure, the patient became symptomatic, presenting with pain and hemorrhage.Per the physician, these symptoms were considered unrelated to the mitraclip procedure.Subsequent x-ray imaging demonstrated complete detachment of the clip from both mitral leaflets.The detached clip was visualized at the bifurcation of the distal iliac aorta.The patient subsequently died.There was no clinically significant delay reported.
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (mr), friable leaflets, thick and flail posterior leaflet and cancer for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.The mr was reduced to grade 1+ post procedure.Post procedure, the patient became symptomatic, presenting with pain and hemorrhage.Per the physician, these symptoms were considered unrelated to the mitraclip procedure.Subsequent x-ray imaging demonstrated complete detachment of the clip from both mitral leaflets.The detached clip was visualized at the bifurcation of the distal iliac aorta.The patient subsequently died due to heart failure.There was no clinically significant delay 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 expulsion.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The case details were reviewed by an abbott senior director of medical affairs.Based on available information, a cause for the reported expulsion could not be conclusively determined.The reported foreign body in patient is a cascading event of the expulsion.The reported pain, death, and hemorrhage appear to be related to worsening patient condition, per case details.The reported patient effects of hemorrhage, pain, and death, as listed in the mitraclip g4 system instructions for use, are known possible complications associated with mitraclip procedures.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: 24344470
• Report Number: 2135147-2026-00932
• Device Sequence Number: 9674432
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)261107(10)51107A1046
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 04/08/2026

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 Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 51107A1046
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG