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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION PROFILE 3D RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Device Problems Gradient Increase; Material Separation; Incomplete Coaptation
Event Date 09/03/2015
Event Type  Injury  
Manufacturer Narrative

Citation: guenzinger r et al. Is a profiled annuloplasty ring suitable for repair of degenerative mitral regurgitation? a single- center experience comprising 200 patients. Thorac cardiovasc surg 2016;64:434¿440. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether these observations have been previously reported. (b)(4).

 
Event Description

Medtronic received information via literature regarding midterm results of patients who underwent mitral valve replacement (mvr) for mitral regurgitation due to degenerative disease with an annuloplasty ring. All data were collected from a single center between june 2009 and june 2011. The study population included 200 patients (predominantly male; mean age 61 years), all of which were implanted with a medtronic profile 3d annuloplasty ring (serial numbers were not provided). Ten deaths were reported within the literature and occurred due to: 2 cardiac related, 1 pneumonia, 7 non-cardiac related or unknown. None of the deaths were attributed to medtronic product. Among all patients adverse events included: 8 thromboembolic events, 6 cerebral vascular accident (cva), 2 transient ischemic attack (tia), mitral valve regurgitation (148 mild, 7 moderate, 4 moderate to severe), and increased gradients. Seven patients required reoperation following ring implant due to the following: 2 endocarditis, 2 ring dehiscence, 1 leaflet suture dehiscence, 1 persistent systolic anterior motion, and 1 native disease progression. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Along with the statement that medtronic product did not cause or contribute to a death or adverse event, the physician/author reply included unique device identifier numbers. A review of these identifier numbers in medtronic's global complaint handling database found no previous product events or previously submitted regulatory reports. 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

Additional information received from physician/author stated: medtronic product did not cause or contribute to any of the observed deaths or adverse events, none of the explanted devices were available for return, and the mean weight of the patient population was 76. 3 kg.

 
Manufacturer Narrative

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

 
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Brand NamePROFILE 3D
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 Key6410540
Report Number2025587-2017-00416
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number680R
Device Catalogue Number680R
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 Received02/16/2017
Was Device Evaluated By Manufacturer? No
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: 03/16/2017 Patient Sequence Number: 1
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