• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING RING, ANNULOPLASTY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING RING, ANNULOPLASTY Back to Search Results
Model Number 620R
Device Problems Detachment Of Device Component; Gradient Increase; Perivalvular Leak
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative

Title: assessment of mitral annuloplasty ring by cardiac computed tomography: correlation with echocardiographic parameters and comparison between two different ring types citation: the journal of thoracic and cardiovascular surgery 2015 volume 150(5):1082-90 (doi 10. 1016/j. Jtcvs. 2015. 07. 019) authors: young joo suh, md, byung-chul chang, md, phd, dong jin im, md, yun jung kim, md, yoo jin hong, md, geu-ru hong, md, phd, and young jin kim, md, phd month and year of 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.

 
Event Description

Medtronic received information via literature review regarding the assessment of mitral annuloplasty rings by cardiac computed tomography. All data were collected from a single center between january 1995 and august 2005. The retrospective study population included 45 patients (predominantly male; mean age 57. 2 years), 18 of which were implanted with medtronic duran mitral annuloplasty ring (serial numbers not provided). Among all patients with this mitral annuloplasty ring, adverse events included: 1 incident of severe paravalvular leak (pvl), 18 incidents of pannus, 9 incidents of stenosis and subsequent increased gradient measurements (> 5 mm hg). Three re-operations were reported one due to stenosis, and two re-operations due to detachment of the ring. No additional adverse patient effects were reported.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDURAN ANCORE RING
Type of DeviceRING, 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 Key5810497
Report Number2025587-2016-01107
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620R
Device Catalogue Number620R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/20/2016 Patient Sequence Number: 1
-
-