• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC PERIMOUNT SURGICAL VALVE; REPLACEMENT HEART-VALVE

  • 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
 

EDWARDS LIFESCIENCES LLC PERIMOUNT SURGICAL VALVE; REPLACEMENT HEART-VALVE Back to Search Results
Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve (b437471), the valve was implanted into a failed edwards perimount surgical valve.No other 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
PERIMOUNT SURGICAL VALVE
Type of Device
REPLACEMENT HEART-VALVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
MDR Report Key17533300
MDR Text Key321043609
Report NumberMW5140204
Device Sequence Number1
Product Code DYE
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 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
-
-