• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB 10
Device Problems Gradient Increase (1270); Obstruction of Flow (2423)
Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335)
Event Date 10/12/2018
Event Type  Injury  
Manufacturer Narrative
Citation: cools b et al.Up to 11 years of experience with the melody valved stent in the right ventricular outflow tract.Eurointervention.2018 oct 12;14(9):e988-e994.Doi: 10.4244/eij-d-18-00054.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 the 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 the reported observations from 11 years of follow-up data after melody valve implantation in the pulmonary position.All data were collected from a single center between 2006 and 2017.The study population included 185 patients (predominantly male; mean age 19 years; mean weight 51.5 kg), all of which were implanted with a medtronic melody bioprosthetic valve (18, 20, and 22 mm prosthesis sizes were used), 23 were previously implanted with a medtronic contegra conduit, 1 was previously implanted with a medtronic hancock conduit, and 3 were previously implanted with a medtronic freestyle bioprosthetic valve.No serial numbers were provided.Among all patients, 3 deaths occurred.The physician/author noted that none of the deaths were related to the valve or the procedure.Based on the available information, medtronic product did not cause or contribute to these deaths.Among all contegra, hancock, and freestyle patients, adverse events included: pulmonary stenosis, pulmonary regurgitation, or a combination of both requiring percutaneous pulmonary valve implantation (melody valve placed inside degenerated bioprosthesis).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, adverse events included: valve explant due to coronary compression (1 case), endocarditis (6 cases), and progressive sub-valvular pulmonary stenosis (1 case), redo percutaneous pulmonary valve implantation due to stenosis after endocarditis (3 cases) or conduit stenosis ¿valve wall thickening¿ 10 years after initial implant (1 case).Other adverse events included: moderate pulmonary regurgitation and increased gradients (unspecified number of cases).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, device malfunctions included: type i stent fractures observed at a mean of 4.2 years after implant (14 cases).No interventions were reported as a consequence of these fractures.Additionally, a type iii stent fracture was observed 5 years after initial implant requiring redo percutaneous pulmonary valve implantation (1 case).Based on the available information, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8271730
MDR Text Key133891799
Report Number2025587-2019-00286
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeBE
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 01/23/2019
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 01/02/2019
Initial Date FDA Received01/23/2019
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;
Patient Age19 YR
Patient Weight52
-
-