MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G5 DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0801-NT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
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
On (b)(6) 2025, a patient was presented with grade 4 degenerative mitral regurgitation (mr), st-segment elevation myocardial infarction, pulmonary edema and pleural effusion for a mitraclip procedure.A mitraclip was successfully implanted.The mr was reduced to grade 2 post procedure.On an unknown day, recurrent mr of grade 3 was observed due to flail and prolapsed leaflets.On (b)(6) 2026, a re-intervention procedure was performed.During the procedure, imaging was challenging.A single leaflet device attachment(slda) occurred from the anterior leaflet.A tear in anterior leaflet was observed.The mr was reduced to grade 2 post procedure.There was no clinically significant delay.
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 incomplete coaptation.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, a cause for the reported incomplete coaptation - single leaflet device attachment (slda) could not be conclusively determined.The cause of the reported suspected anterior leaflet tear could possibly be a cascading effect of the slda.The reported recurrent mitral valve insufficiency/ regurgitation (mr) is likely related to patient anatomy due to residual prolapse with a small flail.Mr and tissue injury are listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported moderately challenging imaging could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances as this was an additional mitraclip procedure to further reduce the mr.
Event or Problem Description
N/a.

• Brand Name: MITRACLIP G5 DELIVERY SYSTEM
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442 2807
• 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: 24210438
• Report Number: 2135147-2026-00458
• Device Sequence Number: 18547833
• Product Code: NKM
• UDI-Device Identifier: 05415067050717
• UDI-Public: (01)05415067050717(17)261125(10)50528R1091
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/18/2026

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: CDS0801-NT
• Device Catalogue Number: CDS0801-NT
• Device Lot Number: 50528R1091
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female