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

Catalog Number UNK CDS

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

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Mitral Valve Stenosis (1965); Syncope/Fainting (4411)

Event Date 05/13/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on the information reviewed and due to the limited information available from the article, the cause of the reported stroke, endocarditis, and mitral stenosis were unable to be determined.The reported syncope was a cascading effect of the reported stroke.The reported patient effect of stroke, endocarditis, and mitral stenosis as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization and medication were the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: date of event was estimated.D4: the udi is unknown as the part and lot numbers were not provided.D6a: date of implant was estimatedna.

Event Description

This is filed to report endocarditis, mitral stenosis, stroke, medication required, and prolonged hospitalization.It was reported that on (b)(6) 2023, a patient presented with secondary mitral regurgitation (mr), multivessel coronary artery disease (ccs class 1), heart failure (hf) with decreased ejection fraction (ef 22%), hypertension, diabetes mellitus type 2, and chronic kidney disease and status post anterior hemicolectomy due to colorectal cancer, with subsequent radiotherapy.The patient was disqualified for cardiac surgery due to the high surgical risk.A mitraclip procedure was performed with good results.Two clips were placed on anterior 2 and posterior 2 leaflets (a2/p2).The maximum and medium gradient values were 9/3 mmhg.Five days after the procedure, on (b)(6) 2023, the patient experienced syncope.A brain computed tomography (ct) showed three hyper-dense focal infarcts in the left occipital, right frontal and right parietal lobe.Repeated echocardiography showed balloting vegetation (22 × × 9 mm) under the left mitraclip.Infective endocarditis was diagnosed.Blood culture showed the presence of methicillin-resistant staphylococcus aureus.Targeted therapy with antibiotics was started and continued for 4 weeks, allowing successful treatment of the patient.At hospital discharge, blood cultures were sterile and no vegetations were visible on echocardiography.No additional information was provided.Details can be found in the attached article titled: "complications following transcatheter edge-to-edge mitral valve repair: personal experience and review of the literature".

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 17107291
• MDR Text Key: 317116594
• Report Number: 2135147-2023-02523
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2023

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/12/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Female