MAUDE Adverse Event Report: ABBOTT MEDICAL TAILORY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Catalog Number UNKTAILORYFLEXANNULOPLASTYBAND

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

Patient Problems Dyspnea (1816); Sepsis (2067)

Event Date 09/22/2023

Event Type  Injury  

Event Description

The article, "staged endoscopic mitral valve repair for active infective endocarditis with a mitral annular abscess", was reviewed.The article presented a case study of a 28-year-old female with prior endoscopic mitral valve repair procedure for active infective endocarditis (aie) with staphylococcus aureus.It was reported that on an unknown date, an unknown tailor band was implanted in a patient's mitral valve for a concomitant mitral valve repair with auto-pericardium patch reconstruction and annuloplasty.It was reported the patient required mechanical respiratory support due to acute respiratory distress syndrome related to sepsis.The patient's condition improved after 6 days post-procedure and transthoracic echocardiography showed moderate mitral regurgitation from the destructed annulus.Computed tomography angiogram (cta) on post-operative day 9 showed cavity formation, an abscess, in the mitral annulus.It was later reported two weeks post-procedure, the tailor band and auto-pericardium patch were explanted and the annulus was repaired with 3-0 mattress pledgetted sutures with bovine pericardium strips, sandwiching the healed myocardium around the annular defect at the anterior commissure.The posterior leaflet was reconstructed with the auto-pericardium, and an annuloplasty was performed.The article concluded a mitral annular abscess may be repaired with staged surgery.[the primary and corresponding author was soh hosoba, japanese red cross nagoya daiichi hospital, 3-35 michishita, nagoya, japan, with corresponding email: sohosoba@gmail.Com].

Manufacturer Narrative

As reported in a research article, staged endoscopic mitral valve repair for active infective endocarditis with a mitral annular abscess.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Na.

• Brand Name: TAILORY FLEXIBLE ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17943590
• MDR Text Key: 325766911
• Report Number: 2135147-2023-04538
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2023

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: UNKTAILORYFLEXANNULOPLASTYBAND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/16/2023
• 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; Hospitalization