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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

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HEART VALVES SANTA ANA 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 Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Event Date 02/25/2012
Event Type  Injury  
Manufacturer Narrative
Date of event: (b)(6) 2012 was an approximation as the re-dilation was reported to have occurred in (b)(6) of 2012. 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 this transcatheter pulmonary valve (tpv), was implanted in a previously placed right ventricle (rv) to pulmonary artery (pa) conduit (20 millimeter (mm) pulmonary graft), in a patient that had complete neonatal repair, truncus arteriosus and a right-sided aortic arch (raa). Approximately one year and seven months following the placement of the valve, angiography showed that the valve was found to be no longer circular and type ii fractures were present. A re-dilation to 22mm was performed, due to tpv compression and recurrent pulmonary stenosis (ps). Approximately eight year and seven months following the placement of the valve, angiography showed moderate pulmonary insufficiency with severe stenosis, and a 38 mm of mercury (hg) across the valve. Multiple stents placed in the right ventricular outflow tract (rvot) for the fractured valve, along with a second tpv implanted valve-in-valve. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Conclusion: the device history record was reviewed and showed that this valve met all manufacturing specifications for product released to distribution. There was no deviation identified in manufacturing process that could be related to this event. Immobile leaflet is a common failure mode (mechanism) which could lead to stenosis/high gradients. Pannus overgrowth is one of the common causes for this failure mode. However, without the failure mechanism and the return of the valve for analysis, a root cause of the stenosis could not be determined. Based on clinical data and literature, melody stent fractures are a known phenomenon. Prominent mechanical stresses on the outflow tract stent, such as compression between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture. It is likely that the reported stent fracture was a type ii fracture with loss of integrity because a new valve was put in place. In this case, with the received information, the stent fracture was caused by the balloon aortic valvuloplasty (bav), which was performed to improve the right ventricle (rv) to pulmonary artery (pa) gradient. In addition, the reported insufficiency and stenosis could be due to the stent fracture. 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)
HEART VALVES SANTA ANA
1851 e deere ave
santa ana CA 92705
MDR Report Key8656107
MDR Text Key146618612
Report Number2025587-2019-01748
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/03/2012
Device Model NumberPB1018
Device Catalogue NumberPB1018
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/30/2019 Patient Sequence Number: 1
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