Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN MITROFLOW AORTIC PERICARDIAL HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNKNOWN MITROFLOW AORTIC PERICARDIAL HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)
Event Type  Injury  
Event Description
Medtronic received information that eight years following the implant of a 21mm mitroflow surgical aortic valve, this transcatheter bioprosthetic valve was implanted valve in valve due to aortic insufficiency verified by echocardiogram.A wire and coronary stent were placed in the left main (lm) coronary artery for protection in case the surgical valve leaflets occluded the lm ostia.The delivery catheter system (dcs) was advanced through the surgical valve without difficulty.Upon recapture of the nose cone, the patient became hypotensive.Cardiopulmonary resuscitation (cpr) was performed.There were no electrocardiogram (ecg) changes indicating that the lm was occluded.An angiogram was not performed due to active cpr, and the coronary stent was deployed.The patient stabilized and cpr was discontinued.An angiogram verified the lm was patent and an echocardiogram verified the heart function.No further treatment was prescribed.The patient was doing well with a positive prognosis.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MITROFLOW AORTIC PERICARDIAL HEART VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
UNKNOWN
MDR Report Key17525637
MDR Text Key321150671
Report NumberMW5132578
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
-
-