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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 Obstruction of Flow (2423)
Patient Problems Stenosis (2263); Regurgitation, Valvular (2335)
Event Date 09/14/2017
Event Type  Injury  
Manufacturer Narrative
Citation: franzone a et al."evolving indications for transcatheter aortic valve interventions." curr cardiol rep.2017 sep 14;19 (11): 107.Doi: 10.1007/s11886-017-0921-3.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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding a review of the progress in the field of transcatheter aortic valve replacement (tavr) including the expansion of indications for tavr as well as future clinical applications.All data were collected from a comprehensive review of data published through 2017.The overall study population included an unidentified number of patients (demographics not provided), a subset of which were implanted with either medtronic corevalve, evolut r, or melody bioprosthetic valves (no serial numbers provided).Among all patients, mortality rates were discussed.However, no specifics about any deaths were reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all corevalve and evolut r patients, adverse events included: permanent pacemaker implantation, stroke/disabling stroke, re-intervention, new-onset atrial fibrillation, myocardial infarction, mild-moderate-severe paravalvular aortic regurgitation, major bleeding, and major vascular complications.Other adverse events noted concerning only corevalve patients: second valve required, conversion to surgery, valve embolization/migration, and aortic valve hospitalization.Based on the available information, medtronic product may have been associated with the adverse events.Among all melody patients, adverse events included: re-intervention and recurrent valve dysfunction defined as significant stenosis or moderate-severe regurgitation.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
 
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Brand Name
MELODY TRANSCATHETER PULMONARY VALVE
Type of Device
PULMONARY 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 Key8624947
MDR Text Key145541561
Report Number2025587-2019-01645
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
H080002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 05/20/2019
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? No
Device Operator Health Professional
Device Model NumberPB 10
Device Catalogue NumberPB 10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2019
Initial Date FDA Received05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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