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

Model Number	CDS0601-XTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ mixed mitral regurgitation (mr), thick leaflets with severe reflux and extensive prolapse for a mitraclip procedure.During the procedure, a mitraclip was implanted and the reflux was controlled.The final mr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2026, it was determined that a single leaflet device attachment has occurred and clip was no longer attached to posterior leaflet and mr has increased and patient returned with congestive heart failure (chf).Surgical treatment of thoracotomy and mitral valve replacement was performed on (b)(6) 2026.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 the reported incomplete coaptation.Additionally, a review of the complaint history identified no similar complaints from the lot.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 congestive heart failure appear to be cascading effects of the reported slda.Mr and congestive heart failure are known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Code 4641 was removed.

• 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: 24214743
• Report Number: 2135147-2026-00499
• Device Sequence Number: 18198881
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260924(10)50924R1071
• 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): 03/17/2026

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 Expiration Date: 09/24/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50924R1071
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown