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

Model Number	CDS0601-XTR
Medical Device Problem Codes	Incomplete Coaptation (2507); Unintended Movement (3026)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 mixed mitral regurgitation (mr), restricted and flail anterior leaflet for a mitraclip procedure.During the procedure, plus knob was unable to respond due to the mechanical jam.An attempt was made to deploy the clip.The clip opened to 60 degree post deployment and had single leaflet device attachment(slda) from the posterior leaflet.Chordal rupture was observed.The mr remained unchanged post procedure.The patient was referred for thoracic surgery.There was no clinically significant delay.
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.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of the complaint history did not indicate a lot-specific product issue.Based on the information reviewed and a cause for the reported unintended movement associated with clip opened while locked resulting in slda, unspecified tissue injury and subsequent unchanged mr cannot be determined.Mitral regurgitation and tissue damage/injury are known possible complications associated with mitraclip procedures.Surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Codes removed: health effect- impact code: 4614.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 mixed mitral regurgitation (mr), restricted and flail anterior leaflet for a mitraclip procedure.During the procedure, plus knob was unable to respond due to the mechanical jam.An attempt was made to deploy the clip.The clip opened to 60 degree post deployment and had single leaflet device attachment(slda) from the posterior leaflet.Chordal rupture was observed.The mr remained unchanged post procedure.The patient was referred for thoracic surgery.There was no clinically significant delay.
Additional Manufacturer Narrative
The reported incomplete coaptation - intraprocedure and unintended movement - clip open ¿ locked could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of the complaint history did not indicate a lot-specific product issue.Based on the information reviewed, the cause for the reported unintended movement associated with clip opened while locked resulting in slda, unspecified tissue injury and subsequent unchanged mr cannot be determined.Mitral regurgitation and tissue damage/injury are known possible complications associated with mitraclip procedures.Surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Codes removed: type of investigation: 4114.Codes 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: 24041173
• Report Number: 2135147-2026-00255
• Device Sequence Number: 10482673
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260812(10)50812R1084
• 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): 02/16/2026

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: 08/12/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50812R1084
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Asian