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

Model Number	CDS0706-NT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning 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+ degenerative mitral regurgitation (mr) and enlarged atrium for a mitraclip procedure.Mitraclip 41002a1070 ntw was implanted successfully.During deployment second mitraclip 40903r1098 nt, difficulty grasping the leaflets was encountered.There was chordal rupture which lead to increase in mr.The device was removed from the anatomy.Third mitraclip 50113a1026 xtw was placed medial to clip 1.The clip was stable on deployment.Fourth mitraclip 50115a1041 xtw was placed medial to clip 1 and lateral to clip 2.An attempt was made to place the fifth mitraclip 50123r1008 xtw lateral to clip 4 and medial to clip 1.Fifth clip was entangled with clip 4 and caused it to shift.There was inadequate grasp of leaflets which lead to unchanged mr.The fifth clip was removed from anatomy.An attempt was made to implant a closure device between first and third mitraclip.During deployment of closure device, it had interaction with mitraclip 1.This made mitraclip 1 to shift and lead to increase in mr to grade 4+.The patient was extubated and was in stable condition.The physician referred the patient for surgery.There was no clinically significant delay.On (b)(6) 2025, the patient had mitral valve and tricuspid valve surgery.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 the reported positioning failure.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported positioning failure (leaflet grasping - clip not implanted, leaflet capture - clip not implanted) appears to be related to challenging patient anatomy (tissue appeared compromised along certain segments of the valve).A cause for the reported tissue injury could not be conclusively determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention, surgical intervention, and hospitalization 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 on (b)(6) 2025 that the patient presented with grade 4+ degenerative mitral regurgitation (mr) and enlarged atrium for a mitraclip procedure.Mitraclip 41002a1070 ntw was implanted successfully.During deployment second mitraclip 40903r1098 nt, difficulty grasping the leaflets was encountered.There was chordal rupture which lead to increase in mr.The device was removed from the anatomy.Third mitraclip 50113a1026 xtw was placed medial to clip 1.The clip was stable on deployment.Fourth mitraclip 50115a1041 xtw was placed medial to clip 1 and lateral to clip 2.An attempt was made to place the fifth mitraclip 50123r1008 xtw lateral to clip 4 and medial to clip 1.Fifth clip was entangled with clip 4 and caused it to shift.There was inadequate grasp of leaflets which lead to unchanged mr.The fifth clip was removed from anatomy.An attempt was made to implant a closure device between first and third mitraclip.During deployment of closure device, it had interaction with mitraclip 1.This made mitraclip 1 to shift and lead to increase in mr to grade 4+.The patient was extubated and was in stable condition.The physician referred the patient for surgery.There was no clinically significant delay.On (b)(6) 2025, the patient had mitral valve and tricuspid valve surgery.No additional information was provided.

• 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: 22347001
• Report Number: 2135147-2025-03498
• Device Sequence Number: 8520129
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)250902(10)40903R1098
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 09/02/2025
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 40903R1098
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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: STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown