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

MAUDE Adverse Event Report: HEART VALVES SANTA ANA 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
 

HEART VALVES SANTA ANA CG FUTURE BAND RING, ANNULOPLASTY Back to Search Results
Model Number 638BL30
Device Problem Incomplete Coaptation (2507)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2016
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation. Conclusion: multiple attempts to request additional information and product return have been made; however, these attempts have been unsuccessful. Without return of the product, no definitive conclusions could be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that 1 years 6 months post implant of this mitral annuloplasty ring, the patient's native valve tissue had a prolapse. The physician explanted the device and implanted a bioprosthetic valve. No further adverse patient effects were reported.

 
Manufacturer Narrative

Additional information received indicates that the patient's device did not cause or contribute to the valve prolapse. The patient experienced cardiogenic shock, extracorporeal membrane oxygenation (ecmo), renal insufficiency, and post operative bell's palsy.

 
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)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5709543
MDR Text Key46909673
Report Number2025587-2016-00851
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052860
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 06/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/26/2016
Device MODEL Number638BL30
Device Catalogue Number638BL30
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 Received06/13/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/07/2011
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: 06/09/2016 Patient Sequence Number: 1
-
-