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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB10F18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Pulmonary Valve Stenosis (2024)
Event Date 02/21/2017
Event Type  Injury  
Manufacturer Narrative
The device remains implanted; therefore, no product analysis can be performed. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that nine years, six months and seven days following the implant of this 18mm transcatheter pulmonary bioprosthetic valve, a balloon angioplasty was performed on the stenotic melody valve. No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information was received which indicated that 70% systemic right ventricular (rv) hypertension from moderate stenosis at the level of the pulmonic valve had also developed. The condition resulted in a balloon aortic valvuloplasty (bav) nine years, six months and one day following the implant of the valve. An 18-millimeter (mm) x4 centimeter (cm) non-medtronic balloon was inflated to 12 standard atmosphere (atms). Trivial gradient (12 millimeters of mercury (mmhg)) was present post procedure. As reported, the bav was successful with good results. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMELODY TRANSCATHER PULMONARY
Type of DevicePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key9226771
MDR Text Key163765197
Report Number2025587-2019-03249
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 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/05/2008
Device Model NumberPB10F18
Device Catalogue NumberPB10F18
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/23/2019 Patient Sequence Number: 1
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