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

Model Number	CDS0601-NTR
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a patient presented with grade 4+ mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.The patient had an ejection fraction value of 37, accompanied by ventricular tachycardia.The patient's left ventricular end-systolic diameter was 60mm, had posterior leaflet tethering of the mitral valve, and pseudo-depression of the anterior leaflet of the mitral valve.The posterior 2 leaflet segment was 8mm in length and the anterior 2 leaflet segment was 20mm in length.A mitraclip ntw was selected for implant.During the procedure, due to the tethering of the posterior leaflet, grasping the leaflets was difficult.Four attempts were made to grasp the leaflets.The posterior leaflet was grasped at 7mm and the anterior leaflet was grasped at 8mm.The clip was closed and it was noted that the mr grade decreased to 2+.However, a partial tearing of the posterior leaflet was observed.The decision was made to fully deploy the clip.The following day on (b)(6) 2025 a single leaflet device attachment (slda) was observed.The posterior leaflet prolapsed, and the clip remained attached to the anterior leaflet.The mr grade increased to 4+.Per the physician, the slda may be related to the tethering of the posterior leaflet because of the multiple grasping attempts.
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, and the reported slda and difficulty grasping could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).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 determined the reported difficulty grasping was due to patient morphology/pathology due to tethering of the posterior leaflet.The reported slda appears to be related to the tissue injury.The reported patient effect of tissue injury appears to be related to multiple grasping attempts.The recurrent mr appears to be due to the slda and dyspnea is a cascading effect of the recurrent mr.Tissue injury, mr and dyspnea are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no additional treatment or intervention was provided.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 a patient presented with grade 4+ mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.The patient had an ejection fraction value of 37, accompanied by ventricular tachycardia.The patient's left ventricular end-systolic diameter was 60mm, had posterior leaflet tethering of the mitral valve, and pseudo-depression of the anterior leaflet of the mitral valve.The posterior 2 leaflet segment was 8mm in length and the anterior 2 leaflet segment was 20mm in length.A mitraclip ntw was selected for implant.During the procedure, due to the tethering of the posterior leaflet, grasping the leaflets was difficult.Four attempts were made to grasp the leaflets.The posterior leaflet was grasped at 7mm and the anterior leaflet was grasped at 8mm.The clip was closed and it was noted that the mr grade decreased to 2+.However, a partial tearing of the posterior leaflet was observed.The decision was made to fully deploy the clip.The following day on (b)(6) 2025 a single leaflet device attachment (slda) was observed.The posterior leaflet prolapsed, and the clip remained attached to the anterior leaflet.The mr grade increased to 4+.Per the physician, the slda may be related to the tethering of the posterior leaflet because of the multiple grasping attempts.

• 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: 22631676
• Report Number: 2135147-2025-04147
• Device Sequence Number: 8936781
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)251127(10)41126R1093
• 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): 08/21/2025

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: 11/27/2025
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 41126R1093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female