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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 Problems Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problems Hematoma (1884); Pulmonary Valve Stenosis (2024)
Event Date 08/03/2018
Event Type  Injury  
Manufacturer Narrative
Citation: shahanavaz s et al. Intentional fracture of bioprosthetic valve frames in patients undergoing valve-in-valve transcatheter pulmonary valve replacement. Circ cardiovasc interv. 2018 aug 3;11(8):e006453. Doi: 10. 1161/circinterventions. 118. 006453. Earliest date of publish used for event date in b3. 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 an effort to identify patient-related, valve-related, or technical factors associated with outcomes of attempted intentional bioprosthetic valve frame fracture in patients who underwent transcatheter valve-in-valve replacement in the pulmonary position. All data were retrospectively collected from 13 centers. The study population included 37 patients with a mean age of 21 years. Of those, 28 were identified as having been implanted with medtronic melody transcatheter pulmonary valves and 3 were previously implanted with medtronic mosaic bioprosthetic valves in the pulmonary position. No serial numbers were provided. Among all mosaic patients, adverse events included: bioprosthetic pulmonary valve dysfunction that required transcatheter valve-in-valve implantation. No other details were reported. Based on the available information, medtronic product was associated with the adverse events. Among all melody patients, adverse events included: valve malposition, residual pulmonary valve stenosis, and a pre-stent dislodged and embolized into the main pulmonary artery during advancement of the melody delivery catheter system that required surgical removal of the pre-stent and valve replacement. Other adverse events observed: retroperitoneal hematoma that required hospitalization and blood transfusion. It was noted that there was no evidence of active bleeding from the vascular access sites related to the retroperitoneal hematoma. 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 NameMELODY TRANSCATHETER PULMONARY VALVE
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 Key9531440
MDR Text Key185034114
Report Number2025587-2019-03915
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 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPB 10
Device Catalogue NumberPB 10
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 Received01/16/2020
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: 12/30/2019 Patient Sequence Number: 1
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