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

Catalog Number CDS0705-XTW

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

Patient Problems Endocarditis (1834); Fever (1858); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

The clip remains 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.Date of event is estimated.Date of implant is estimated.

Event Description

This is filed to report endocarditis.It was reported that roughly one month ago, a mitraclip procedure was performed to treat mitral regurgitation (mr) with an unknown grade.An unknown number of clips were implanted, reducing mr to an unknown grade.Roughly one month later, the patient returned with endocarditis.

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, a cause for the reported endocarditis could not be determined.The reported mitral regurgitation (mr) and fever appear to be cascading events of the endocarditis.Furthermore, the reported patient effects of endocarditis, mr, and fever, are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported hospitalization and medication were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initially filed report, additional information was received stating on (b)(6) 2022, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.It was noted the patient had erythroderma, hypertension, dyslipidemia, pneumoconiosis.One clip was deployed on the mitral valve, reducing mr to a grade of 1.On (b)(6) 2022, the patient returned to the hospital due to a fever.Mr had increased to a grade of 2-3 and endocarditis was observed.For treatment, antibiotics were administered.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15761805
• MDR Text Key: 303344423
• Report Number: 2135147-2022-02011
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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: 05/23/2023
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20524R167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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; Other; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 57 KG