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

Catalog Number UNK CDS

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

Patient Problems Arrhythmia (1721); Endocarditis (1834); Fatigue (1849); Fever (1858); Hypoxia (1918); Unspecified Infection (1930); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Respiratory Failure (2484); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported recurrent mitral regurgitation (mr), fatigue, fever, arrhythmia, hypoxia, respiratory failure, infection, endocarditis, shock, and ventricular fibrillation.Mr, fatigue, fever, arrhythmia, hypoxia, respiratory failure, infection, endocarditis, shock, and ventricular fibrillation are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization, medication required, unexpected medical interventions and surgical interventions were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B3: date estimated.D4: the udi number is not known as the part and lot number were not provided.Article titled, "rapidly progressive infective endocarditis after mitraclip therapy: a rare complication of transcatheter edge-to-edge mitral valve repair.".

Event Description

This is filed to report all serious injuries, requiring intervention.It was reported in an article that the patient underwent a mitraclip procedure to treat severe functional mitral regurgitation (mr) with tethered leaflets.A nasal culture was performed before mitraclip therapy and it was positive for methicillin-resistant staphylococcus aureus (mrsa), suggesting that the patient was an asymptomatic carrier of mrsa.Therefore, a single dose of vancomycin (1000 mg) was administered before the mitraclip therapy to prevent periprocedural infection.An nt mitraclip was successfully implanted reducing mr to mild.One month post procedure, the patient returned with general fatigue and a high fever.The patient had unstable hemodynamics and a blood pressure of 90/54 mmhg, a heart rate of 100 beats/min, and oxygen saturation of 89 %.Antibiotic therapy was initiated for possible community-acquired infection and possible infective endocarditis (ie).Subsequently, two sets of blood cultures were positive for mrsa, suggesting mitraclip related ie.The respiratory condition of the patient deteriorated rapidly, necessitating the use of mechanical ventilator supported management the following day.Transthoracic echocardiography (tte) and subsequent transesophageal echocardiography (tee) revealed severe mr due to rapidly progressing degenerative anterior mitral leaflet with aneurysmal formation.During the tee examination, cardiogenic shock caused by heart failure deterioration and subsequent ventricular fibrillation occurred.Emergency extracorporeal cardiopulmonary resuscitation (ecpr) with combined therapy of intra-aortic balloon pumping (iabp) and venoarterial extracorporeal membrane oxygenation (va-ecmo) was required.Under catecholamine support and antibiotic therapy, the unstable condition due to acute infection was ameliorated, and va-ecmo was safely removed on day 5.Under iabp support alone, the patient was successfully extubated without cerebral dysfunction on day 7.Finally, surgical intervention was performed to treat the destructive mitral valve and a non-abbott mitral valve was implanted.No additional information was provided.Details are listed in the attached titled, ¿rapidly progressive infective endocarditis after mitraclip therapy: a rare complication of transcatheter edge-to-edge mitral valve repair.¿.

• Brand Name: MITRACLIP® SYSTEM 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: 16752878
• MDR Text Key: 313425688
• Report Number: 2135147-2023-01680
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2023

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: 03/27/2023
• Initial Date FDA Received: 04/17/2023
• 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): Life Threatening; Required Intervention; Disability; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male