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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB 10
Device Problems Fracture (1260); Gradient Increase (1270)
Patient Problems Aneurysm (1708); Occlusion (1984); Pulmonary Regurgitation (2023)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
Citation: eicken, a. Md. Percutaneous pulmonary valve implantation (ppvi): indications and outcome (2014). Year of presentation was used for event date. No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature review regarding a presentation on percutaneous pulmonary valve implantation. All data were collected from a single center, registry and a medtronic sponsored clinical study. Patient were implanted with a medtronic melody transcatheter pulmonary valve and a non-medtronic transcatheter pulmonary valve. Serial numbers were not provided. The study population was predominantly male; mean age 18. 9 years; mean weight 60. 8 kg. Among all patients adverse events included: balloon aortic valvuloplasty (bav) that resulted in grade 2-3 stent fractures, valve-in-valve, trivial to severe pulmonary regurgitation with subsequent increased gradient measurements, coronary artery occlusion, right ventricular outflow tract (rvot) aneurysm treated with stent placement, pulmonary artery perforation and valve replacement. No additional adverse patient effects or product performance issues were reported.
 
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Brand NameMELODY TRANSCATHETER 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 Key7119548
MDR Text Key94927970
Report Number2025587-2017-02447
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPB 10
Device Catalogue NumberPB 10
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 Received11/20/2017
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: 12/14/2017 Patient Sequence Number: 1
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