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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); No Consequences Or Impact To Patient (2199)
Event Date 09/20/2018
Event Type  Injury  
Manufacturer Narrative
Product analysis: the product remains implanted therefore no product analysis can be completed. Conclusion: without 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 an unknown time following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was reported to have multiple stent fractures. A second non-medtronic valve was implanted inside of the valve. No additional adverse patient effects were reported.  .
 
Manufacturer Narrative
Additional information received that approximately five years and nine months post implant of the pulmonary valve, the valve was replaced due to elevated pressures and gradients with severe stenosis. A valvuloplasty was performed followed by stent placement and an additional dilatation. A non-medtronic valve was then successfully implanted. No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.
 
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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 Key7957130
MDR Text Key123419171
Report Number2025587-2018-02716
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received11/06/2018
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: 10/11/2018 Patient Sequence Number: 1
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