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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY Back to Search Results
Model Number 620B
Device Problem Inadequacy of Device Shape and/or Size
Event Date 04/26/2017
Event Type  Injury  
Manufacturer Narrative

The device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that immediately post implant of this annuloplasty band, this device was explanted and replaced with a device with a larger size. A nurse in the physician's practice stated that the device was the wrong size for the patient. No other adverse patient effects were reported.

 
Manufacturer Narrative

Patient information updated in section.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

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Brand NameRING 620RG33 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 Key6583772
Report Number2025587-2017-00843
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number620B
Device Catalogue Number620BG33
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 Received06/13/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/04/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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