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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 40MM RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 40MM RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Device Problems Inadequacy of Device Shape and/or Size; Insufficient Information
Event Date 03/02/2017
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for device analysis. Conclusion: multiple attempts to gather additional information and request 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. 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 following implant of this annuloplasty ring, it was explanted and replaced. No failure mechanism was provided. No other adverse patient effects were reported.

 
Event Description

Medtronic received information that immediately following implant of this annuloplasty ring, it was explanted and replaced because it was the incorrect size for the patient. No other adverse patient effects were reported.

 
Manufacturer Narrative

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

 
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Brand NameRING PROFILE 3D 40MM
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 Key6411975
Report Number2025587-2017-00421
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/03/2017
Device MODEL Number680R
Device Catalogue Number680R40
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 Received04/25/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/23/2012
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: 03/16/2017 Patient Sequence Number: 1
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