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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
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 identified no similar complaints reported from this lot.Based on available information, the reported single leaflet device attachment (slda) was due to anatomy of this patient and poor imaging.The reported poor imaging resolution was due to patient anatomy (huge left atrium and left ventricle).There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
N/a.
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.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr), two ventricular aneurysms and cardiac transposition for a mitraclip procedure.During the procedure, imaging was difficult.One mitraclip was successfully implanted.During deployment of second mitraclip, partial clip detachment from anterior leaflet was observed.The procedure was terminated with removal of the second clip and no change in mr post procedure.There was no clinically significant delay.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr), two ventricular aneurysms and cardiac transposition for a mitraclip procedure.During the procedure, imaging was difficult.One mitraclip was successfully implanted.During deployment of second mitraclip, partial clip detachment from anterior leaflet was observed.The procedure was terminated with removal of the second clip and no change in mr post procedure.There was no clinically significant delay.
Additional Manufacturer Narrative
The device was initially not returned for analysis and was returned for analysis at a later date.The reported incomplete coaptation (single leaflet device attachment) could not be replicated in a testing environment.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 identified no similar complaints reported from this lot.Based on available information, the reported single leaflet device attachment (slda) was due to anatomy of this patient and poor imaging.The reported poor imaging resolution was due to patient anatomy (huge left atrium and left ventricle).There is no indication of a product issue with respect to manufacture, design or labeling.Code removed: type of investigation: 4117.Code added: type of investigation: 10.

• 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: 23956556
• Report Number: 2135147-2026-00061
• Device Sequence Number: 5611020
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260924(10)50924R1047
• 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): 02/04/2026

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 Expiration Date: 09/24/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50924R1047
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Sex: Unknown