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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA RING PROFILE 3D 26MM RING, ANNULOPLASTY

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HEART VALVES SANTA ANA RING PROFILE 3D 26MM RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2016
Event Type  Injury  
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).

 
Event Description

Medtronic received information that immediately following implant of this 26 mm annuloplasty ring in the mitral position, it was explanted and replaced with a 27 mm bioprosthetic valve. The ring was deemed to have been too small, which has been attributed to user error. No adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: investigation results indicate that there are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate result. This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring. In this case, the ring was deemed to have been too small, which has been attributed to user error. Overall there is no indication of product quality issue.

 
Manufacturer Narrative

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

 
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Brand NameRING PROFILE 3D 26MM
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5457372
MDR Text Key38906556
Report Number2025587-2016-00224
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,Followup
Report Date 03/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/09/2020
Device MODEL Number680R
Device Catalogue Number680R26
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 Received03/14/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/22/2015
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: 02/24/2016 Patient Sequence Number: 1
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