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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); Material Rupture (1546); Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)
Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Endocarditis (1834); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Tissue Damage (2104); Vascular System (Circulation), Impaired (2572); Blood Loss (2597); Pericardial Effusion (3271)
Event Date 04/21/2019
Event Type  Injury  
Manufacturer Narrative
Citation: nordmeyer j et al. Acute and midterm outcomes of the post-approval melody registry: a multicentre registry of transcatheter pulmonary valve implantation. Eur heart j. 2019 jul 14;40(27):2255-2264. Doi: 10. 1093/eurheartj/ehz201. Epub 2019 apr 21. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding the outcomes after transcatheter pulmonary valve implantation (tpvi) using the melody valve in patients with congenital heart disease. All data were retrospectively collected from 42 centers between december 2006 and september 2013. The study population included 845 patients and was predominantly male with a mean age of 21 years and a mean weight of 59 kg. All were implanted with medtronic melody transcatheter pulmonary valves. No serial numbers were provided. Among all patients, 13 deaths were reported. The causes of death were due to tpvi endocarditis (9), coronary artery compression (3), and bleeding after conduit rupture (1). Based on the available information, medtronic product was associated with these deaths. Among all patients, adverse events included: reoperation and valve explantation due to endocarditis, stenosis, stent fractures, or chronic pericardial effusion; balloon dilation of the melody valve or valve-in-valve reintervention due to pulmonary restenosis, stent fractures, or endocarditis; coronary artery compression that required surgical treatment; bleeding due to conduit rupture that required interventional treatment; bleeding due to pulmonary artery injury that required interventional or surgical treatment; valve dislodgement; obstruction of pulmonary artery branches that required interventional treatment; arrhythmia; dislocation of pacemaker/implantable cardioverter defibrillator leads; injury of a right ventricular papillary muscle; pulmonary embolism; pulmonary edema; balloon rupture that required interventional treatment; and vascular access complications that required interventional or surgical treatment. Based on the available information, medtronic product was associated with the adverse events. 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 Key9525865
MDR Text Key187046788
Report Number2025587-2019-03894
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 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
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 Received12/04/2019
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: 12/27/2019 Patient Sequence Number: 1
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