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

Model Number	CDS0601-XTR
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ degenerative mitral regurgitation (mr) and prolapsed posterior leaflet for a mitraclip procedure.During the procedure, difficulty was encountered while grasping the leaflets.One mitraclip was successfully implanted.The mr was reduced to grade 1+ post procedure.On (b)(6) 2025, follow up revealed single leaflet device attachment(slda) from the posterior leaflet.Patient returned symptomatic with dyspnea and angina.The minus knob was unable to straighten the sleeve.Per the physician, knob functionality affected adequate grasping of leaflets which may have resulted in slda.Angina was resolved by percutaneous intervention.Recurrent mr of grade 4+ was reported.There was no clinically significant delay.
Additional Manufacturer Narrative
The device remains implanted in 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 identified no similar complaints reported from this lot.The investigation was unable to determine the cause for the reported difficult positioning of leaflet grasping and the single leaflet device attachment (slda).The reported patient effect of mitral regurgitation, dyspnea, and angina, as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.The reported recurrent mr was a cascading event of the reported slda.The reported dyspnea and angina were cascading effect of recurrent mitral valve regurgitation.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
N/a.

• 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: 24081831
• Report Number: 2135147-2026-00317
• Device Sequence Number: 17589806
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260924(10)50924R3022
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/31/2026

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: 50924R3022
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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: STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown