MAUDE Adverse Event Report: Abbott Medical MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Heart Block (4444)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ degenerative mitral regurgitation (mr), thick and flail leaflet for a mitraclip procedure.During the procedure, while deploying the clip, patient had hypotension, bradycardia and heart block.Epinephrine is given to the patient.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ degenerative mitral regurgitation (mr), thick and flail leaflet for a mitraclip procedure.During the procedure, while deploying the clip, patient had hypotension, bradycardia and heart block.Epinephrine is given to the patient.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
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.
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.Based on the information received, the cause of the reported bradycardia, hypotension, and heart block could not be conclusive determined.The reported patient effects of hypotension, bradycardia, and heart block are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MitraClip G5 Delivery System
• Common Device Name: mitral valve repair devices
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Northpoint Reg 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50282746
• Report Number: 2135147-2026-05642
• Device Sequence Number: 9753335
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• UDI-Public: (01)05415067050779(17)270802(10)60202A1043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/27/2026

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 Model Number: CDS0801-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60202A1043
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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
• Patient Age: 78 YR
• Patient Sex: Male