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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Mitral Regurgitation (1964); Obstruction/Occlusion (2422)
Event Date 02/19/2016
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for evaluation. Conclusion: the causes of re-operation for failed repairs are well documented in the literature. Reoperations are primarily the result of a progression of disease or technical failures and not related to product malfunctions. Unlike bioprosthetic heart valves, annuloplasty rings are an adjunct to the valve repair. This investigation found no intrinsic evidence to suggest a root cause related to manufacturing. 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 approximately 2 years post implant of this annuloplasty ring, it was explanted and replaced with a bioprosthetic valve. Transesophageal echocardiogram (tee) revealed high velocity flow, increased gradients, central regurgant jet, and left ventricular outflow tract (lvot) obstruction. The patient experienced shortness of breath and fatigue. The annuloplasty ring was reported to be too small for the patient's anatomy. No further 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 24MM
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 Key5752599
MDR Text Key48271364
Report Number2025587-2016-00938
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 06/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/05/2017
Device MODEL Number680R
Device Catalogue Number680R24
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 Manufactured10/25/2012
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: 06/27/2016 Patient Sequence Number: 1
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