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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 28MM RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 28MM RING, ANNULOPLASTY Back to Search Results
Model Number 680R28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Mitral Regurgitation (1964)
Event Date 07/16/2020
Event Type  Injury  
Manufacturer Narrative

Product analysis: no product was returned. 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 this patient's native mitral valve was degenerated and regurgitation was present. The surgeon first repaired the leaflets and then reinforced the annulus with this annuloplasty ring. Testing of the valve revealed residual regurgitation. It was reported that the patient's cardiomyopathy was impairing the leaflets from coapting appropriately. As a result, the annuloplasty ring was explanted and a bioprosthetic valve was implanted. No additional adverse patient effects were reported.  .

 
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Brand NameRING PROFILE 3D 28MM
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 Key10313945
MDR Text Key200050791
Report Number2025587-2020-02316
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number680R28
Device Catalogue Number680R28
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/27/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2020
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: 07/23/2020 Patient Sequence Number: 1
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