• 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 BAND 620BG31 DURAN ANCORE ANNULOPLASTY C 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 BAND 620BG31 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY Back to Search Results
Model Number 620BG31
Device Problems Incomplete Coaptation; Insufficient Information
Event Date 10/02/2018
Event Type  Injury  
Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that five months and twenty-seven days post implant of this 31mm mitral annuloplasty ring, the ring was explanted and replaced with a 25mm bioprosthetic valve for unknown reasons. No additional adverse patient effects were reported.  .

 
Manufacturer Narrative

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

 
Event Description

Medtronic received information that five months and twenty-seven days post implant of this 31mm mitral annuloplasty band, the band was explanted and replaced with a 25mm bioprosthetic valve. The reason for explant was reported as severe mitral regurgitation, with retraction of the anterior leaflet. A gap was noted between the anterior and posterior leaflets, along with the a3 and p3. Despite multiple attempts to wean from bypass, the right ventricle (rv) was not functioning as expected. The surgeon placed the patient on extracorporeal membrane oxygenation (ecmo) and no additional adverse patient effects were reported.  .

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBAND 620BG31 DURAN ANCORE ANNULOPLASTY C
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 Key7985020
Report Number2025587-2018-02781
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620BG31
Device Catalogue Number620BG31
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 Received11/13/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/10/2017
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: 10/19/2018 Patient Sequence Number: 1
-
-