MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Model Number	CDS0706-NTW
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Na.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.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr) and dilated left and right ventricle for a mitraclip procedure.During the procedure, one mitraclip was successfully implanted.Following deployment of a second mitraclip xtw, mitral regurgitation (mr) worsened.A third mitraclip ntw was attempted; however, resistance was encountered while advancing the clip lateral to the xtw.Fluoroscopy revealed entanglement between the ntw and xtw clips.During troubleshooting, it was observed that the xtw grippers were not engaged with the leaflets, and its gripper assembly remained intact with the distal end of the ntw, contributing to the entanglement.Single leaflet device attachment (slda) of the xtw clip from the anterior leaflet occurred during the disentanglement process.The ntw clip was successfully deployed with adequate leaflet grasp.An atrial septal defect (asd) had occurred.Patient experienced hypoxia.A non-abbott device was used for asd closure.The patient was placed on intra-aortic balloon pump (iabp) support in intensive care unit (icu).Post-procedure, mr was reduced to grade 3+.There was no clinically significant procedural delay.No additional information was provided.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4+ functional mitral regurgitation (mr) and dilated left and right ventricle for a mitraclip procedure.During the procedure, one mitraclip was successfully implanted.Following deployment of a second mitraclip xtw, mitral regurgitation (mr) worsened.A third mitraclip ntw was attempted; however, resistance was encountered while advancing the clip lateral to the xtw.Fluoroscopy revealed entanglement between the ntw and xtw clips.During troubleshooting, it was observed that the xtw grippers were not engaged with the leaflets, and its gripper assembly remained intact with the distal end of the ntw, contributing to the entanglement.Single leaflet device attachment (slda) of the xtw clip from the anterior leaflet occurred during the disentanglement process.The ntw clip was successfully deployed with adequate leaflet grasp.A atrial septal defect (asd) had occurred.Patient experienced hypoxia.A non-abbott device was used for asd closure.The patient was placed on intra-aortic balloon pump (iabp) support in intensive care unit (icu).Post-procedure, mr was reduced to grade 3+.There was no clinically significant procedural delay.No additional information was provided.
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 difficult or delayed positioning and device damaged by another device (caused damage) appeared to be related to procedural conditions.A cause for the reported physical resistance/sticking could not be determined.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.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 22999064
• Report Number: 2135147-2025-05080
• Device Sequence Number: 21212138
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)260121(10)50122R1114
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 01/21/2026
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 50122R1114
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 95 KG