• 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 CG FUTURE BAND 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 CG FUTURE BAND RING, ANNULOPLASTY Back to Search Results
Model Number 638R
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Mitral Regurgitation (1964)
Event Date 11/09/2015
Event Type  Injury  
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).

 
Event Description

Medtronic received information that after the physician implanted this 32mm annuloplasty ring in the mitral position and the ring was sutured into place, there was residual mitral regurgitation. The device was removed and successfully replaced with a 30mm annuloplasty ring. No further adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: surgeons often attempt to repair valves in lieu of replacing them due to improved long-term clinical outcomes. There are times when a valve repair is attempted using a repair device and subsequent post repair evaluation demonstrates an inadequate result. This is likely due to suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.

 
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 NameCG FUTURE BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5399157
MDR Text Key37130290
Report Number2025587-2016-00104
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/04/2020
Device MODEL Number638R
Device Catalogue Number638RL32
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 Received02/15/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/18/2015
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: 01/29/2016 Patient Sequence Number: 1
-
-