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

Model Number	CDS0701-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	09/25/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2020, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and pre-existing posterior flail.A mitraclip xtw was inserted and deployed medially on the mitral valve.A second mitraclip, a mitraclip xt, was then inserted and deployed on the mitral valve, lateral to the first clip, reducing mr to a grade of 1-2.It was noted that the clips appeared to be stable.On (b)(6) 2026, an echocardiogram was performed and revealed a posterior flail that the mitraclip xt had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4.It was noted that it was uncertain if the mitraclip xt had worsened the posterior flail.Due to declining health, the patient urgently underwent a second mitraclip procedure on the same day.One clip was implanted, and the mr remained at a grade of 4.It was noted that the patient required hospitalization.On (b)(6) 2026, the patient presented to the hospital in heart failure, requiring a balloon pump and other supports.The patient died.In the physician's opinion, the cause of death was not due to the procedure on (b)(6) 2026, but instead heart failure and other complications related to the slda clip from (b)(6) 2020.No further information was reported.
Additional Manufacturer Narrative
The clip remains in the 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.
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.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 determined.The reported recurrent mitral valve insufficiency/ regurgitation (mr) and new flail are likely a cascading effect of the slda.The cause of the reported heart failure and subsequent patient death could not be determined.Mr, heart failure, tissue injury, and death are known possible complication associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP
• 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 ; 6517565400
• MDR Report Key: 24234854
• Report Number: 2135147-2026-00567
• Device Sequence Number: 13319381
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: (01)08717648230981(17)210728(10)00728U291
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Expiration Date: 07/28/2021
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 00728U291
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2020
• 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; Other; Hospitalization; Required Intervention
• Patient Sex: Unknown