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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 Material Separation (1562); Incomplete Coaptation (2507)
Patient Problems Endocarditis (1834); Mitral Regurgitation (1964)
Event Date 02/11/2017
Event Type  Injury  
Manufacturer Narrative

Citation: sideris k et al. Functional and degenerative mitral regurgitation: one ring fits all thorac cardiovasc surg. 2019 sep 23. Doi: 10. 1055/s-0039-1696989. Presented at the 46th annual meeting of the german society for thoracic and cardiovascular surgery (dgthg), leipzig, february 11¿14, 2017. 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 via literature regarding the mid-term outcomes in patients who underwent mitral valve repair for degenerative mitral regurgitation and functional mitral regurgitation using a rigid three-dimensional ring. All data were collected from a single center between june 2009 and february 2016. The study population included 369 patients and was predominantly male with a mean age of 65 years. All were implanted with medtronic profile 3d annuloplasty rings. No serial numbers were provided. Among all patients, 9 deaths occurred during the initial hospitalization due to cardiac-related causes (5) and non-cardiac-related causes(4). An additional 25 patients died at a mean time of 2. 3 years post-implant due to cardiac-related causes (1), non-cardiac-related causes (5), and unknown causes (19). No other details were reported. Based on the available information, medtronic product was not directly associated with the deaths. Among all patients, adverse events included: reoperation/mitral valve re-repair due to ring dehiscence, endocarditis, or systolic anterior motion. Other adverse events observed: mild-moderate-severe mitral regurgitation. Based on the available information, medtronic product was directly associated with the adverse events. No additional adverse patient effects or product performance issues were reported.

 
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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 Key9410565
MDR Text Key169243686
Report Number2025587-2019-03663
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK073324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 12/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received11/14/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/04/2019 Patient Sequence Number: 1
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