MAUDE MDR 50941437

MDR report key
50941437
Report number
9617601-2026-05864
Event key
0
Event type
3
Date of event
2026-08-18
Date received
2026-09-30
Adverse event
1
Product problem
1
Patients in event
0
Reporter occupation
1
Health professional
1
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
Alison Sweeney
Address
Parkmore Business Park West Galway EI
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
353652Medtronic Transcatheter ValveAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVMedtronic Mexico S. De R.L. De CVNPTMDT-TRANS VALVEMDT-TRANS VALVEN
418188Medtronic Transcatheter ValveAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVMedtronic Mexico S. De R.L. De CVNPTMDT-TRANS VALVEMDT-TRANS VALVEN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-09-300L; H; R

Event Narratives#

No narrative records found.