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

Model Number	CDS0801-XT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shock (2072); Unspecified Tissue Injury (4559)
Date of Event	07/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 3+ mixed mitral regurgitation (mr), prolapsed posterior leaflet, coaptation gap of nearly 10 mm and enlarged atrium for a mitraclip procedure.The initial screening mr grade 3+ but worsened to 4+ at the start of the procedure.The cause was unknown.During the procedure, the mitraclip xtw was implanted.The decision was made to implant a second mitraclip xt.Grasping was attempted and after a few grasping attempts, it was observed that there was a torn anterior leaflet.The second mitraclip xt was removed from the patient.The first clip remained stable.The final mr was grade 4+.The following day, the patient went into shock and passed away.The patient's family declined additional intervention and medical therapy.The physician believed worsening heart failure and significantly severe mr prior to the procedure, in addition to the torn tissue likely contributed to the death.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 3+ mixed mitral regurgitation (mr), prolapsed posterior leaflet, coaptation gap of nearly 10 mm and enlarged atrium for a mitraclip procedure.The initial screening mr grade 3+ but worsened to 4+ at the start of the procedure.The cause was unknown.During the procedure, the mitraclip xtw was implanted.The decision was made to implant a second mitraclip xt.Grasping was attempted and after a few grasping attempts, it was observed that there was a torn anterior leaflet.The second mitraclip xt was removed from the patient.The first clip remained stable.The final mr was grade 4+.The following day, the patient went into shock and passed away.The patient's family declined additional intervention and medical therapy.The physician believed worsening heart failure and significantly severe mr prior to the procedure, in addition to the torn tissue likely contributed to the death.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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.The provided event details was reviewed by an abbott director of medical affairs.The investigation was unable to determine the cause for the reported unspecified issue injury, death, and shock.Unspecified issue injury, death, and shock are listed in the instructions for use as known possible complications associated with the mitraclip procedures.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: 50326466
• Report Number: 2135147-2026-05681
• Device Sequence Number: 9758158
• Product Code: NKM
• UDI-Device Identifier: 05415067050762
• UDI-Public: (01)05415067050762(17)270721(10)60120A1054
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/24/2026

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-XT
• Device Catalogue Number: CDS0801-XT
• Device Lot Number: 60120A1054
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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: 1 X Mitraclip; Steerable guide catheter
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown