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

Model Number	CDS0601-NTR
Medical Device Problem Codes	Incomplete Coaptation (2507); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, prolapsed anterior leaflet, short posterior leaflet, large gap between anterior and posterior leaflets, dilated left atrium, dilated left ventricle, and 6-7mm posterior leaflet.A steerable guide catheter (sgc) and a mitraclip ntr clip delivery system (cds) were inserted and successfully delivered to the left atrium.However, after the cds was delivered to the left ventricle, imaging revealed that the cds swayed significantly along with the sgc with the heartbeat.It was noted that the sgc touched the ventricular muscle.The clip was deployed on the mitral valve.However, post deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).No additional clips were implanted, and the mr remained at a grade of 4+.Due to the significant swing of the clip, the patient was transferred to surgery for thoracotomy and mitral valve repair surgery.The patient was reported to be stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
All available information was investigated.The returned device analysis was unable to confirm the reported unintended movement.The reported incomplete coaptation and poor imaging 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 unintended movement appears to be related to procedural conditions (sgc in contact with ventricular muscle).The reported incomplete coaptation and poor imaging appear to be related to challenging patient anatomy (large gap between leaflets).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.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, prolapsed anterior leaflet, short posterior leaflet, large gap between anterior and posterior leaflets, dilated left atrium, dilated left ventricle, and 6-7mm posterior leaflet.A steerable guide catheter (sgc) and a mitraclip ntr clip delivery system (cds) were inserted and successfully delivered to the left atrium.However, after the cds was delivered to the left ventricle, imaging revealed that the cds swayed significantly along with the sgc with the heartbeat.It was noted that the sgc touched the ventricular muscle.The clip was deployed on the mitral valve.However, post deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).No additional clips were implanted, and the mr remained at a grade of 4+.Due to the significant swing of the clip, the patient was transferred to surgery for thoracotomy and mitral valve repair surgery.The patient was reported to be stable.

• 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: 23794959
• Report Number: 2135147-2025-07344
• Device Sequence Number: 12190743
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)260424(10)50424R1057
• 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
• Device Explanted 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): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 50424R1057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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; Hospitalization
• Patient Sex: Unknown