FDA.reportPublic FDA data

MAUDE MDR 9900208

MDR report key
9900208
Report number
2025587-2020-01008
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-30
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
1EVOLUT R TRANSCATHETER AORTIC VALVEAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVEREDMEDTRONIC HEART VALVES DIVISIONNPTEVOLUTR-34-USEVOLUTR-34-US* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. D

Event Narratives#

N

Patient 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ENVPRO-16-US, SERIAL/LOT #: (B)(4), UBD: 24-JUL-2021, UDI#: (B)(4). PRODUCT ANALYSIS: THE VALVE REMAINS IMPLANTED AND THE DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE 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 PATIENT BECAME HEMODYNAMICALLY UNSTABLE FOLLOWING THE FIRST ATTEMPT TO DEPLOY THE VALVE, WHICH WAS PARTIALLY DEPLOYED TO 80%. THE VALVE DISLODGED OUT OF ANNULAR SEATING AND WAS IMMEDIATELY RECAPTURED. THE PATIENT?S PRESSURES BECAME UNSTABLE AND REMAINED THAT WAY WITHOUT RECOVERING DESPITE ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) EFFORTS. THE VALVE WAS REPOSITIONED A SECOND TIME AND WAS FULLY DEPLOYED SUCCESSFULLY, RESULTING IN AN OPTIMAL IMPLANT DEPTH. THE PATIENT WAS CLOSELY MONITORED HOWEVER THE PRESSURES REMAINED SUB-OPTIMAL. IT WAS REPORTED THAT THE CORONARY EMBOLIZATION AND LEFT MAIN CORONARY ARTERY OCCLUSION CAUSED THE PATIENT TO BECOME HEMODYNAMICALLY UNSTABLE. PER THE PHYSICIAN, THE CAUSE OF THE CORONARY OCCLUSION WAS THE EMBOLIZATION. THE CAUSE OF THE EMBOLIZATION WAS UNKNOWN. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS (CPB) AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE WHERE THE TRANSCATHETER VALVE WAS EXPLANTED. THE PATIENT DIED FOLLOWING THE OPEN SURGICAL PROCEDURE. THE CAUSE OF DEATH WAS NOT REPORTED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.