FDA.reportPublic FDA data

MAUDE MDR 9908967

MDR report key
9908967
Report number
2025587-2020-01040
Event key
0
Event type
3
Date of event
2018-11-27
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1EVOLUT R TRANSCATHETER AORTIC VALVEAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVEREDMEDTRONIC HEART VALVES DIVISIONNPTEVOLUTR-26EVOLUTR-26* 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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED AFTER A BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO HYPO-EXPANSION OF THE VALVE. MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. A SECOND VALVE WAS IMPLANTED AND MODERATE PVL WAS REPORTED. NO TREATMENT WAS PRESCRIBED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST VALVE DISLODGED AFTER A BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO HYPO-EXPANSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.?