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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Ischemia (1942); Vascular Dissection (3160)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Literature article: short- and midterm outcomes of modified robotic tricuspid annuloplasty for secondary tricuspid regurgitation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, ¿short- and midterm outcomes of modified robotic tricuspid annuloplasty for secondary tricuspid regurgitation¿, was reviewed.The article presents a retrospective single center study experience to review early outcomes of robotic tricuspid annuloplasty (tap) with and without mitral valve repair to evaluate its safety and feasibility.Devices included in this study were tailor band st jude medical inc., saint paul, mn, usa or simuplus band (medtronic inc., minneapolis, mn, usa).The article concluded that robotic tricuspid annuloplasty with continuous sutures is safe and feasible alone or concomitant with mitral valve repair.It offered sustained improvement in tr severity and might prevent heart failure readmission.[the primary and corresponding author was satoshi kainuma, departments of cardiac surgery, national cerebral and cardiovascular center, suita, osaka, japan, with corresponding email: (b)(6)] the time frame of the study was from april 2018 to december 2021.A total of 68 patients were included in this study with the average age of 74 years and average gender was male.Comorbidities included atrial fibrillation, hypertension, hypercholesterolemia, diabetes mellitus, coronary artery disease, coped, renal dysfunction, thyroid hyperfunction.

Manufacturer Narrative

Summarized patient outcomes/complications of the tailor flexible annuloplasty band were reported in a research article in a subject population with multiple co-morbidities including atrial fibrillation, hypertension, hypercholesterolemia, diabetes mellitus, coronary artery disease, coped, renal dysfunction, thyroid hyperfunction.Some of the complications reported were aortic dissection, surgical intervention, myocardial ischemia, cerebral infarction, surgical intervention, hospitalization, and bleeding.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 17455096
• MDR Text Key: 320374578
• Report Number: 2135147-2023-03402
• 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,Followup
• Report Date: 09/06/2023

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: 07/11/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 09/06/2023
• 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