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

Catalog Number CDS0705-NTW

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

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Fever (1858)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported endocarditis cannot be determined.Fever and cerebrovascular accident however, appear to be cascading effects of endocarditis.Endocarditis, fever and cerebrovascular accident are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that a 92-year-old patient with grade 4 mixed mitral regurgitation and a prolapsed posterior leaflet was treated on (b)(6) of 2023.One mitraclip was reported and the mr was reduced to grade 1-2.The patient was hospitalized on (b)(6) of 2023, and had developed infective endocarditis and subsequent fever and asymptomatic cerebral infarction.Vegetations were observed on the valve leaflets by echocardiogram.Medication was provided as treatment.Penicillin was administered.Per the physician the mitraclip possibly contributed to the endocarditis.The patient recovered and there were no adverse patient sequelae.No additional information was provided.

• 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: 18020383
• MDR Text Key: 326707947
• Report Number: 2135147-2023-04732
• 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: Other
• Type of Report: Initial
• Report Date: 10/27/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 20404R168
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 92 YR
• Patient Sex: Female