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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTOUR 3D ANNULOPLASTY RING RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION CONTOUR 3D ANNULOPLASTY RING RING, ANNULOPLASTY Back to Search Results
Model Number 690R30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complete Heart Block (2627)
Event Date 02/17/2020
Event Type  Injury  
Manufacturer Narrative

Citation: werner p et al. Extra-anatomic aortic bypass with aortic-, mitral-, and tricuspid surgery in a (b)(6) year old: a single-stage approach for complex coarctation associated with triple valve pathology. J card surg. 2020 apr;35(4):937-939. Doi: 10. 1111/jocs. 14465. Epub 2020 feb 17. Earliest date of publish used for date of event. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information from a literature case report regarding a (b)(6) year old female patient with a history of hypertension and chronic obstructive pulmonary disease who presented with dyspnea related to multiple valve pathology with associated coarctation. Transesophageal echocardiography revealed a stenotic bicuspid aortic valve and insufficient mitral and tricuspid valves. A single-stage surgical repair of coarctation associated with the aortic, mitral, and tricuspid valves was performed. During the procedure, the patient¿s native mitral valve was deemed not repairable. Consequently, a non-medtronic mechanical valve was implanted in the mitral position followed by aortic valve replacement with a non-medtronic mechanical valve. Lastly, the patient¿s tricuspid valve was repaired with a 30 mm medtronic contour 3d annuloplasty ring (serial number not provided). Following the procedure, the patient had complicated respiratory weaning and spent thirty-nine days on a respirator. On an unspecified date between completion of the procedure and hospital discharge, a permanent pacemaker was implanted due to total atrioventricular block. The patient was discharged in improved general condition seventy-nine days after the procedure. No additional adverse patient effects or product performance issues were reported.

 
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Brand NameCONTOUR 3D ANNULOPLASTY RING
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 Key10371013
MDR Text Key209167721
Report Number2025587-2020-02514
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK101212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number690R30
Device Catalogue Number690R30
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 Received09/02/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/10/2019
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: 08/05/2020 Patient Sequence Number: 1
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