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

Catalog Number CDS0701-NT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Swelling/ Edema (4577)

Event Date 02/06/2024

Event Type  Injury  

Event Description

This report is being filed due to worsening heart failure with recurrent mitral regurgitation, deemed device related and requiring treatment.Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on 08/19/2021, the patient presented with mixed mitral regurgitation (mr) with anterior and posterior leaflet prolapse and leaflet tethering.One mitraclip was successfully implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2024, the patient was admitted to the hospital with lower extremity edema and mild shortness of breath.Worsening congestive heart failure (chf) was diagnosed, treated with medications.During this hospitalization, mitral valve stenosis, severe mr, and tricuspid valve regurgitation with mild pulmonary hypertension were diagnosed.On (b)(6) 2024, the patient was admitted to the hospital for a scheduled right heart catheterization.Elevated filling pressures with evidence of acute heart failure exacerbation were reported.Medications were provided as treatment.

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 cause of the reported heart failure, recurrent mitral regurgitation, mitral stenosis, hypertension, tricuspid regurgitation, swelling, and dyspnea were unable to be determined.The reported patient effects of mitral regurgitation, heart failure, mitral stenosis, hypertension, tricuspid regurgitation, edema, and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: 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: 18862153
• MDR Text Key: 337182388
• Report Number: 2135147-2024-01051
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10313R227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 54 KG