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

Model Number	CDS0706-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4 degenerative mitral regurgitation, a posterior calcium shelf with short restricted posterior leaflet and elevated starting gradient for a mitraclip procedure.During the procedure there was challenges in reducing the mr.A mitraclip xtw and a mitraclip nt were attempted but were not implanted.During the grasping attempts, there was a tissue perforation noted on the posterior leaflet.Per the physician, there were no device malfunctions.The final mr was grade 3-4.There were no clinically significant delays reported.An additional medical procedure has been scheduled.
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported unspecified tissue injury appears to be related to patient conditions (calcified, thin, short and restricted posterior leaflet).Tissue damage/injury is a known possible complication associated with mitraclip procedures.Unexpected medical 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.

• 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: 22237855
• Report Number: 2135147-2025-03261
• Device Sequence Number: 15728012
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)251111(10)41112A1119
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/16/2025

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: 11/11/2025
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 41112A1119
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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