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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM RING, ANNULOPLASTY

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HEART VALVES SANTA ANA RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM RING, ANNULOPLASTY Back to Search Results
Model Number 690R36
Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problems Tricuspid Insufficiency (2111); No Information (3190)
Event Date 08/30/2016
Event Type  Injury  
Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation. 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.

 
Event Description

Medtronic received information that 7 years post implant of this mitral bioprosthetic valve, it was explanted and replaced. No failure mechanism was provided. No other adverse patient effects were reported.

 
Manufacturer Narrative

Medtronic received additional information that a 36mm tricuspid annuloplasty band was implanted and then explanted immediately following due to insufficiency. This was replaced with a 32mm tricuspid annuloplasty band. No other adverse patient effects were reported. 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.

 
Manufacturer Narrative

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

 
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Brand NameRING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM
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 Key5963888
MDR Text Key55161716
Report Number2025587-2016-01498
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101212
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 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number690R36
Device Catalogue Number690R36
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 Received10/06/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/26/2016
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: 09/20/2016 Patient Sequence Number: 1
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