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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES LLC PERIMOUNT MAGNA VALVE; REPLACEMENT HEART-VALVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hemothorax (1896)
Event Type  Injury  
Event Description
Medtronic received information that one day following the implant of an edwards perimount magna valve, a right hemathorax was noted.Subsequently, emergency surgical re-exploration was performed and the hemothorax was drained.No further 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).
 
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Brand Name
PERIMOUNT MAGNA VALVE
Type of Device
REPLACEMENT HEART-VALVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
MDR Report Key17537423
MDR Text Key321068622
Report NumberMW5144301
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 04/17/2017
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
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