Device adverse event reports (MAUDE)

Medtronic Transcatheter Valve · AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Medtronic Mexico S. De R.L. De CV · Gradient Increase, Patient Device Interaction Problem

InjuryInitial submissionMDR 50941437
Manufacturer link flag
Y
Manufacturer g1 city
Tijuana,BC
Manufacturer contact address 1
Parkmore Business Park West
Manufacturer contact pcity
+353(091
Event type
Injury
Report number
9617601-2026-05864
Product problem flag
Y
Date received
20260930
PMA pmn number
P130021
Date of event
20260818
Reprocessed and reused flag
N
Reporter occupation code
PHYSICIAN
Manufacturer contact plocal
+353(091)708096
Noe summarized
1
Manufacturer contact l name
Sweeney
Manufacturer g1 postal code
22210
Reporter country code
AU
Date added
20260930
Manufacturer contact f name
Alison
Previous use code
I
Mfr report type
Thirty-Day
Manufacturer contact country
EI
Date changed
20260930
Health professional
Y
Summary report flag
N
Date report
20260929
Manufacturer g1 country
MX
Manufacturer contact city
Galway
MDR report key
50941437
Date manufacturer received
20260918
Report source code
Manufacturer report
Manufacturer g1 zip code
22210
Manufacturer g1 name
Medtronic Mexico S. De R.L. De CV
Adverse event flag
Y
Single use flag
Y
Manufacturer g1 address 1
Av. Paseo del Cucapah #10510
Type of report
Initial submission
Source type
Foreign, Literature
Device
  1. Device sequence number
    353652
    Serviced by 3rd party flag
    N
    Date received
    20260930
    Brand name
    Medtronic Transcatheter Valve
    Generic name
    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
    Manufacturer d name
    Medtronic Mexico S. De R.L. De CV
    Manufacturer d address 1
    Av. Paseo del Cucapah #10510
    Manufacturer d city
    Tijuana,BC
    Manufacturer d zip code
    22210
    Manufacturer d country
    MX
    Manufacturer d postal code
    22210
    Device operator
    HEALTH PROFESSIONAL
    Model number
    MDT-TRANS VALVE
    Catalog number
    MDT-TRANS VALVE
    Device availability
    No
    Device report product code
    NPT
    Combination product flag
    N
    Harmonized identifiers (openFDA)
    Device name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Medical specialty description
    Unknown
    Device class
    3
Product problems
Gradient Increase, Patient Device Interaction Problem
Patient
  1. Patient sequence number
    1
    Date received
    20260930
    Patient age
    82 YR
    Patient sex
    Male
    Sequence number outcome
    Life Threatening, H, R
    Patient problems
    Pericardial Effusion
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.