FDA.reportPublic FDA data

MAUDE MDR 9908800

MDR report key
9908800
Report number
2025587-2020-01039
Event key
0
Event type
3
Date of event
2017-05-31
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAULA BIXBY
Address
8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MELODY TRANSCATHER PULMONARY VALVEPULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVEREDMEDTRONIC HEART VALVES DIVISIONNPVPB1018PB1018* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS AND TEN MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE VALVE WAS REPLACED VALVE-IN-VALVE DUE TO SEVERE PULMONARY INSUFFICIENCY AND RIGHT VENTRICLE DILATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.