MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FLEXIBLE BAND; RING, ANNULOPLASTY

Model Number 700FC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Blood Loss (2597); Vascular Dissection (3160)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

Citation: murphy, e.Md et atl.The expanding role of endoscopic robotics in mitral valve surgery: 1,257 consecutive procedures.The society of thoracic surgeons.(2015).Nov;100(5):1675-81 doi 10.1016/j.Athoracsur.2015.05.068 earliest date of e-publish/publish used for event date.  no unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding the use of endoscopic robotics during the implant of a mitral valve annuloplasty ring or band.All data were collected from a single center between 2006 and 2013.The study population included 1,257 patients, some of which were implanted with a simulus annuloplasty ring/band.Serial numbers were not provided.The study population was predominantly male; mean age 59.3 ± 20.5 years of age.Among all patients adverse events included: conversion to sternotomy, bleeding, dissection, ring/band dehiscence, reoperation, stroke, infection, mild to moderate mitral regurgitation, atrial fibrillation, mitral stenosis, recurrent prolapse, endocarditis, thrombus and systolic anterior movement.Based on the available information, these events may have been attributed to a medtronic product.No additional adverse patient effects or product performance issues were reported.

• Brand Name: SIMULUS FLEXIBLE BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7409832
• MDR Text Key: 104797994
• Report Number: 2025587-2018-00816
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2018

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 Model Number: 700FC
• Device Catalogue Number: 700FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/09/2018
• 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: 59 YR