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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.
 
Manufacturer Narrative
Device mfg date: added (b)(6) 2007.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MELODY TRANSCATHER PULMONARY
Type of Device
PULMONARY 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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/05/2008
Device Model NumberPB10F18
Device Catalogue NumberPB10F18
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/03/2019
Initial Date FDA Received10/23/2019
Supplement Dates Manufacturer Received10/03/2019
12/18/2019
02/21/2020
Supplement Dates FDA Received12/18/2019
12/20/2019
03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age29 YR
Patient Weight68
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