MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; Mitral Valve Repair Devices

Model Number	CDS0601-NTR
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 3+functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a mitraclip ntr was successfully placed on the leaflets when the mean pressure gradient (mpg) was measured to be 10 mmhg.The clip was removed, and the procedure was discontinued when the mpg returned to baseline.The final mr remained at grade 3+.There were no adverse patient effects or clinically significant delays reported.It was reported that on (b)(6) 2026, the patient had a follow-up examination when it was identified that the mr increased to grade 4+.A postoperative ultrasound identified tissue damage to the valve leaflets.The patient remained in the hospital for continued medication treatment.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be filed with additional information.

• 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 ; +1(651)756-5400
• MDR Report Key: 25152733
• Report Number: 2135147-2026-03176
• Device Sequence Number: 9397224
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)261204(10)51203R1040
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 51203R1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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; Hospitalization; Other
• Patient Sex: Unknown