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

Model Number CDS0701-NTW

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

Patient Problems Endocarditis (1834); Pain (1994)

Event Date 04/12/2022

Event Type  Injury  

Event Description

This report is being filed due to endocarditis requiring treatment, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) grade 4+, with dilated cardiomyopathy.One mitraclip was implanted, reducing the mr to grade 1+.On (b)(6) 2022, the patient as admitted to the hospital with back, left shoulder and lower back pain.Infective endocarditis was diagnosed.Medications were provided and a blood transfusion was performed as treatment.The event resolved and the patient was discharged from the hospital.Per physician, the event was unknown if device related.There was no device malfunction.No additional information was provided regarding this issue.

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 endocarditis was unable to be determined.The reported pain appears to be related to the reported endocarditis.The reported patient effect of endocarditis and pain, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported medication required, hospitalization, and unexpected medical intervention (blood transfusion) 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
• 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: 16405935
• MDR Text Key: 309879964
• Report Number: 2135147-2023-00594
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 02/20/2023

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: 05/24/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10520R287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 47 KG