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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB10
Device Problem Gradient Increase (1270)
Patient Problems Unspecified Infection (1930); Thrombus (2101)
Event Date 01/09/2017
Event Type  Injury  
Manufacturer Narrative
The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.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
Medtronic received information that two years following the implant of this transcatheter bioprosthetic pulmonary valve, the patient presented with an acute infection.The blood culture was positive for corynebacterium jeikeium.A positron emission tomography (pet) scan was negative for endocarditis.Two weeks following the blood cultures, thrombosis was noted on the valve.A pulmonary valve obstacle was noted with a gradient of 52/34 mmhg.Subsequently, a second pulmonary valve was implanted valve-in-valve.No other adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MELODY TRANSCATHER PULMONARY
Type of Device
PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
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 Key6507965
MDR Text Key73328759
Report Number2025587-2017-00619
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPB10
Device Catalogue NumberPB1018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2017
Initial Date FDA Received04/20/2017
Supplement Dates Manufacturer Received03/30/2017
Supplement Dates FDA Received10/02/2017
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 YR
Patient Weight72
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