• 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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Fistula (1862); Hemolysis (1886); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Transient Ischemic Attack (2109)
Event Date 10/13/2005
Event Type  Injury  
Manufacturer Narrative

Citation: david t et al. A comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse. J thorac cardiovasc surg. 2005 nov;130(5):1242-9. Doi: 10. 1016/j. Jtcvs. 2005. 06. 046. Epub 2005 oct 13. 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. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information via literature regarding a comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse. All data were collected from a single center between july 1981 and june 2001. The study population included 701 patients (predominantly male, overall mean age 56. 7 years), 166 of whom were implanted with medtronic duran ring (no serial numbers provided) for mitral valve surgical repair. Among all patients there were 5 operative and 98 late deaths (18 valve-related, 32 cardiac, and 48 non-cardiac deaths). The authors discussed predictors of these deaths, but no further details were provided regarding the causes of death. Based on the available in formation medtronic product may have been associated with the death(s). Among all patients, adverse events included: stroke, transient ischemic attack (tia), major hemorrhage during anticoagulation therapy, infective endocarditis, severe mitral regurgitation (mr), and atrial fibrillation. Additionally the following adverse events required reoperation: severe mr, hemolysis caused by residual mr, mitral stenosis caused by pannus, infective endocarditis, and left ventricular-coronary sinus fistula. Based on the available information medtronic product may have been associated with the adverse event(s). No additional adverse patient effects or product performance issues were reported.

 
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 Key10433923
MDR Text Key203905766
Report Number2025587-2020-02642
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK960356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2020
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 Received08/13/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 08/20/2020 Patient Sequence Number: 1
-
-