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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number NU 10
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Hemostasis (1895); Pulmonary Valve Stenosis (2024); Sepsis (2067); Regurgitation (2259); Obstruction/Occlusion (2422); Blood Loss (2597); Pseudoaneurysm (2605)
Event Date 12/06/2017
Event Type  Injury  
Manufacturer Narrative
Citation: cabalka ak et al. Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: a multicenter study. J thorac cardiovasc surg. 2018 apr;155(4):1712-1724. E1. Doi: 10. 1016/j. Jtcvs. 2017. 10. 143. Epub 2017 dec 6. 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding the safety and effectiveness of melody valve function in patients who underwent transcatheter pulmonary valve replacement (tpvr) into a dysfunctional pulmonary bioprosthetic valve (bpv). All data were collected from 10 centers between january 2010 and june 2015. The study population included 100 patients (predominantly male; mean age 22 years; mean weight 62 kg), all of which were implanted with a medtronic melody transcatheter pulmonary valve, and 20 of which had a previously implanted medtronic hancock bioprosthetic valve or a medtronic mosaic bioprosthetic valve in the pulmonary position. No serial numbers were provided. Among all patients, adverse events included: valve-in-valve implantation (melody valve placed into dysfunctional surgical bpv), 1 case of streptococcus viridans endocarditis with sepsis 18 months following tpvr procedure, pulmonary stenosis, severe pulmonary regurgitation, moderate obstruction, high right ventricular outflow tract gradients, and 1 case of vascular access site bleeding requiring transfusion and surgical repair of a femoral arteriovenous fistula and pseudoaneurysm 6 weeks after tpvr procedure. Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product. No additional adverse patient effects or product performance issues were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
Type of DevicePULMONARY 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 Key7695622
MDR Text Key114279598
Report Number2025587-2018-01772
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNU 10
Device Catalogue NumberNU 10
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
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