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

Catalog Number CDS0702-XTW

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

Patient Problems Endocarditis (1834); Fever (1858); Unspecified Infection (1930); Sepsis (2067); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 10/03/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a patient adverse event leading to death.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr).One clip was implanted with no reported issue.Signs of infection presented at one month follow-up.On (b)(6) 2022, the patient presented with fever and was hospitalized the next day.On (b)(6) 2022, severe mr and perforation was observed on transoesophageal echocardiography (tee).On (b)(6) 2022, a large vegetation next to the mitraclip was observed on tee.On (b)(6) 2022, the patient was presented with high inflammatory laboratory markers, sepsis, poor condition, and the patient expired.

Event Description

This is filed to report adverse patient effect leading to death.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade of 4.One clip was implanted with no reported issue, reducing mr to grade 1.Signs of infection presented at 1 month follow-up.On (b)(6) 2022, the patient presented with fever and was hospitalized the next day.On (b)(6) 2022, severe mr and perforation was observed on transoesophageal echocardiography (toe).On (b)(6) 2022, a large vegetation next to the mitraclip was observed on toe.On (b)(6) 2022, the patient was presented with high inflammatory laboratory markers, endocarditis, sepsis, poor condition, and the patient expired.No additional information was provided.

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 infection and tissue injury were unable to be determined.The reported endocarditis and fever were cascading events of the reported infection.The reported sepsis was a cascading event of the reported sepsis.The reported patient death was a cascading event of the reported sepsis.The reported recurrent mr was a cascading event of the reported tissue injury.The reported patient effect of infection, fever, endocarditis, sepsis, death, tissue injury, and mitral regurgitation as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization was the result 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
• 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: 16454228
• MDR Text Key: 310364192
• Report Number: 2135147-2023-00762
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 03/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20427R275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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): Death; Other; Hospitalization
• Patient Age: 81 YR