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

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with mixed mitral regurgitation with posterior leaflet prolapse.One mitraclip was implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2024, a follow-up echocardiogram was performed.Recurrent mr grade 2+ and a mean mitral valve gradient of 6.4mmhg was noted.On (b)(6)2024, the patient was admitted to the hospital with shortness of breath and acute on chronic congestive heart failure was diagnosed.Per imaging, severe pulmonary hypertension, along with moderate mitral stenosis with an elevated bnp lab (heart failure) had been noted.Medications were provided as treatment.The patient had a drop in hemoglobin and additional gastrointestinal work-up is ongoing.There was no overt bleeding observed.There was no indication the hemoglobin drop was cardiac-device related.There was no device malfunction.No additional information was provided regarding this issue.
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 investigation was unable to determine a cause for the reported recurrent mitral regurgitation (mr), hypertension, and mitral stenosis.The dyspnea and heart failure appear to be cascading effects of the recurrent mr.Mr, heart failure, dyspnea, hypertension, and mitral stenosis are listed in the instructions for use is a known possible complication associated with mitraclip procedures.The reported hospitalization and medication required were results of case specific circumstances as the patient was admitted to the hospital due to the patient effects and medications were provided as treatment.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previous report, the additional information was received: there was no treatment for the elevated gradient.

• Brand Name: G4 MITRACLIP CLIP 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 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: 21083829
• Report Number: 2135147-2025-00143
• Device Sequence Number: 6728286
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 08/09/2022
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10809R125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 114 KG