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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB1018
Device Problems Fracture (1260); Gradient Increase (1270)
Patient Problems Pulmonary Valve Stenosis (2024); Right Ventricular Dysfunction (2054)
Event Date 02/01/2014
Event Type  Injury  
Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.   conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately two years, six months, and thirteen days following the implant of this transcatheter bioprosthetic pulmonary valve into a stenotic 17 millimeter (mm) homograft, the valve was balloon dilated using a 22 millimeter (mm) non-medtronic balloon. The reason for dilation was not able to be confirmed, however it was suspected to be performed due to increased right ventricular (rv) pressure and increased rv-pulmonary artery (pa) pressures. Approximately nine years and fifteen days following the valve implant, the patient presented with moderate stenosis of the valve due to type ll (nordmeyer classification) stent fractures, right ventricular dilatation and dysfunction, a peak to peak gradient of approximately 50 mmhg, and right ventricular systolic pressures of 75 mmhg which is 2/3 of the systemic pressure. No treatment was performed. No additional adverse patient effects were reported.  .
 
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Brand NameMELODY TRANSCATHER PULMONARY VALVE
Type of DevicePULMONARY 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 Key10460600
MDR Text Key204574115
Report Number2025587-2020-02688
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/07/2013
Device Model NumberPB1018
Device Catalogue NumberPB1018
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 Received10/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2011
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: 08/27/2020 Patient Sequence Number: 1
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