MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Endocarditis (1834); Fatigue (1849); Fever (1858); Inflammation (1932); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article titled "mitraclip- associated ineffective endocarditis on 2-[18f] fdg pet/ct"na.

Event Description

This is filed to report endocarditis and recurrent mitral regurgitation.It was reported through a research article that a patient underwent a mitraclip procedure in 2019 to treat mitral regurgitation (mr) with a grade of 4.One clip was successfully deployed on the mitral valve.Roughly two years later, the patient returned to the hospital due to asthenia, fever, recurrent mr and pain in his right ankle.A transesophagael echocardiogram was performed and showed infective endocarditis (ie) as vegetation was visible on the implanted clip.For treatment, medication was administered.It was noted that after six weeks of medication, the patient became clinically stable and the vegetation and mr had disappeared.Additional details are listed in the article, titled "mitraclip- associated ineffective endocarditis on 2-[18f] fdg pet/ct." no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and database for the reported lot could not be performed as the lot number and part number are unknown.Based on available information, a cause for the reported endocarditis could not be determined.The reported fatigue, fever, mitral regurgitation (mr) and inflammation appear to be cascading effect of endocarditis.Fever, endocarditis and mr are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Hospitalization and medical intervention are the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.G2 - report source updated from "foreign/health professional/company representative" to "literature".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12988954
• MDR Text Key: 286939623
• Report Number: 2024168-2021-11512
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Male