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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Valve Stenosis (2024)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
: the event date/explant date was reported to be in (b)(6) of 2015. The exact date remains unknown. Product analysis: the product remains implanted; therefore, no product analysis can be performed.   conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately one and a half years following the implant of this transcatheter pulmonary bioprosthetic valve (tpbv), residual stenosis due to dynamic subpulmonic obstruction occurred. The tpbv was removed and a surgical valve was then implanted. 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 Key7422414
MDR Text Key105188798
Report Number2025587-2018-00838
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/08/2015
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 Received03/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/22/2013
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: 04/11/2018 Patient Sequence Number: 1
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