MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0601-XTR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	07/16/2025
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.Patient had dilated cardiomyopathy, left ventricular end-systolic diameter 70mm, and posterior leaflet restriction.A xtr clip was implanted reducing mr to grade 1+.Five days after the procedure (b)(6) 2025, the patient died from cerebral hemorrhage.There were no reported device issue with the xtr or the steerable guide catheter during the initial procedure.Post procedure the clip was reported to remain stable on both leaflets and no tissue damage was observed.The cause of the cerebral hemorrhage was reported to be unknown.
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 available information, the reported death appears to be related to intracranial hemorrhage.However, a cause for the reported intracranial hemorrhage could not be determined.The reported patient effect of death and intracranial hemorrhage, as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.Patient had dilated cardiomyopathy, left ventricular end-systolic diameter 70mm, and posterior leaflet restriction.A xtr clip was implanted reducing mr to grade 1+.Five days after the procedure (b)(6) 2025, the patient died from cerebral hemorrhage.There were no reported device issue with the xtr or the steerable guide catheter during the initial procedure.Post procedure the clip was reported to remain stable on both leaflets and no tissue damage was observed.The cause of the cerebral hemorrhage was reported to be unknown.

• Brand Name: MITRACLIP
• 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: 22815722
• Report Number: 2135147-2025-04554
• Device Sequence Number: 9014389
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260228(10)50227R1003
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 02/28/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50227R1003
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown