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

Catalog Number CDS0602-NTR

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

Patient Problems Endocarditis (1834); Inflammation (1932)

Event Date 01/13/2021

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.

Event Description

This is filed to report endocarditis, and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.On (b)(6) 2020, one clip was successfully deployed, reducing mr to <1.Then on (b)(6) 2021, the patient was readmitted to the hospital with inflammation and pain in the left hip.Transesophageal echocardiogram (tee) was performed and showed vegetation on the mitral valve and on the mitra clip.Staphylococcus epidermidis (skin germ) was detected in the blood culture.The physician stated that it is unknown if the hip infection led to the endocarditis or if the clip caused the infection.The patient was referred to cardiology and was treated with antibiotic therapy.On (b)(6) 2021, the vegetation on the mitral valve declined and the patient was discharged home with oral antibiotic therapy.The clip remains stable on both leaflets, and mr is <1.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 the reported event.Based on the available information, the reported inflammation appears to have been an outcome of the reported endocarditis.A cause for the reported endocarditis could not be determined.The reported patient effect of endocarditis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization and required medication were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11602933
• MDR Text Key: 243403425
• Report Number: 2024168-2021-02623
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 04/17/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 00416U138
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention