MAUDE Adverse Event Report: Abbott Medical MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/04/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr), thin friable tissue for a mitraclip procedure.During the procedure, two mitraclip xt were implanted.During implantation of a third mitraclip xt, multiple grasps were made on the friable tissue.A leaflet tear was then observed.The third clip was removed from the patient and replaced with a mitraclip nt.The third clip was implanted.The final mr remained at grade 4.On (b)(6) 2026 the patient presented with heart failure with a v wave of 70mmhg.A balloon pump was inserted but did not resolve symptoms.The patient passed away.The clips remained stable at the time of death.The physician believed the tissue injury was due to the mitraclip and overall tissue integrity.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr), thin friable tissue for a mitraclip procedure.During the procedure, two mitraclip xt were implanted.During implantation of a third mitraclip xt, multiple grasps were made on the friable tissue.A leaflet tear was then observed.The third clip was removed from the patient and replaced with a mitraclip nt.The third clip was implanted.The final mr remained at grade 4.On (b)(6) 2026 the patient presented with heart failure with a v wave of 70mmhg.A balloon pump was inserted but did not resolve symptoms.The patient passed away.The clips remained stable at the time of death.The physician believed the tissue injury was due to the mitraclip and overall tissue integrity.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 this event.Based on available information, the cause of the reported death, mitral valve regurgitation, and heart failure were unable to be determined.The reported patient effects of death, mitral regurgitation, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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
• 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 ; +1(651)756-5400
• MDR Report Key: 50500551
• Report Number: 2135147-2026-05887
• Device Sequence Number: 9405128
• Product Code: NKM
• UDI-Device Identifier: 05415067050717
• UDI-Public: (01)05415067050717(17)270929(10)60401R1064
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NT
• Device Catalogue Number: CDS0801-NT
• Device Lot Number: 60401R1064
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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: 2XMitraclips.; Steerable guide catheter.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male