MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION PROFILE 3D; RING, ANNULOPLASTY

Model Number 680R

Device Problem Material Separation (1562)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Pleural Effusion (2010); Tachycardia (2095); Transient Ischemic Attack (2109); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Vascular System (Circulation), Impaired (2572); Complete Heart Block (2627); No Information (3190); Pericardial Effusion (3271)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

Citation: doll n et al.Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair.Eur j cardiothorac surg.2019 feb 1; 55 (2): 217-223.Doi: 10.1093/ejcts/ezy215.Advance access publication 21 june 2018.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the patient outcomes following mitral valve repair using a three-dimensional saddle-shaped, rigid ring.All data were collected from 7 centers between february 2013 and july 2015.The study population included 148 patients (predominantly male; mean age 64 years), all of which were implanted with medtronic profile 3d annuloplasty rings (no serial numbers provided).Among all patients, 3 deaths occurred (1 cardiac, 2 non-cardiac).Two deaths occurred within 30 days post implant and 1 death occurred more than 30 days post implant.All 3 deaths were considered ¿possibly related to the implant procedure.¿ based on the available information, medtronic product may have been associated with the deaths.Among all patients, adverse events included: explant due to ring dehiscence (1 case) and early recurrence of mitral insufficiency (1 case).Other adverse events reported: conversion to mitral valve replacement surgery (2 cases for unknown reasons), major stroke, minor stroke, myocardial infarction, ring dehiscence, major hemorrhage, minor hemorrhage, atrioventricular block (first-, second-, and third-degree), left ventricular outflow tract obstruction, worsening of mitral insufficiency, mild-moderate-severe mitral regurgitation, pericardial effusion, pleural effusion, atrial fibrillation, atrial flutter, bradycardia, junctional rhythm, left and right bundle branch block, sick sinus syndrome, tachycardia (supraventricular and ventricular), and ventricular fibrillation.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: PROFILE 3D
• 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: 8712095
• MDR Text Key: 148425788
• Report Number: 2025587-2019-01976
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 680R
• Device Catalogue Number: 680R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• 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: 64 YR