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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 Problem Material Deformation (2976)
Patient Problems Atrial Flutter (1730); Dyspnea (1816); Pulmonary Valve Stenosis (2024); Heart Failure/Congestive Heart Failure (4446); Pulmonary Valve Insufficiency/ Regurgitation (4452); Respiratory Insufficiency (4462); Swelling/ Edema (4577)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative
Citation: kuc m et al. Successful pulmonary homograft re-implantation after previous surgical and percutaneous interventions. Kardiologia polska. 2018 february; 76(2):471. Doi: 10. 5603/kp. 2018. 0042. Published online: february 16, 2018. Earliest date of publish used for date of event. 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a literature case report regarding a male patient with a medical history of tetralogy of fallot with absent pulmonary valve requiring primary repair (at (b)(6) years of age) and later underwent surgical allograft repair due to allograft stenosis (at (b)(6) years of age). Seven years later (at (b)(6) years of age), due to recurrence of pulmonary allograft stenosis, the patient underwent transcatheter pulmonary valve implantation with a medtronic melody (serial number not provided). After the procedure, a right ventricular outflow tract (rvot) peak gradient of 18 mmhg was observed. One-week after melody implant, transthoracic echocardiography (tte) was performed and revealed a gradient of 76/36 mmhg. Two months after melody implant, the valve was expanded with a 22-mm balloon. Following the balloon dilation, the gradient was 35 mmhg, and subsequent tte showed a rvot gradient of 78/44 mmhg. Recurrent stent recoil was diagnosed. The patient was referred to surgery, but did not give consent. Six years after melody implant (at (b)(6) years of age), the patient presented with heart failure and paroxysmal atrial flutter, which impaired cardiac function causing dyspnea at rest and peripheral edema. Tte revealed pulmonary valve stenosis with peak/mean gradient of 130/75 mmhg and small pulmonary valve insufficiency. Cardiac magnetic resonance imaging exhibited large dysfunctional right heart chambers. Computed tomography scan showed stenosis of the pulmonary artery close to the bifurcation and damaged melody valve leaflets. Subsequently, the melody valve and pulmonary allograft were surgically explanted. A 25 mm pulmonary allograft was implanted using root-replacement technique. In the post-operative period, the patient endured right heart insufficiency, which was treated with diuretics. Tte confirmed good allograft function, which was reflected by a peak gradient of 16 mmhg. The patient was discharged 13 days after surgery in good condition without peripheral edema. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key10945507
MDR Text Key219503669
Report Number2025587-2020-03680
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodePL
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
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
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 Received12/10/2020
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: 12/04/2020 Patient Sequence Number: 1
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