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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN VALSALVA AORTIC PROSTHESIS
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SORIN SORIN VALSALVA AORTIC PROSTHESIS Back to Search Results
Model Number CP-027
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Chills (2191); Malaise (2359)
Event Date 03/25/2015
Event Type  Injury  
Event Description
Patient diagnosed with prosthetic valve endocarditis and/or aortic graft infection following aortic valve and aortic root replacement.Patient complained of low grade fever, chills and malaise 4-6 weeks after the initial postop visit.No obvious signs of infection were noted during the office visit approx 3 months post op.Patient admitted to the hosp 21 days later with complaints of chills, cough and fatigue.Serum cultures showed no growth after 5 days but were positive for mycobacterium chelonae-abscessus on day 6.Prosthetic aortic valve and root replacement were removed, cultured and sent to the mfr for investigation.
 
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Brand Name
SORIN VALSALVA AORTIC PROSTHESIS
Type of Device
SORIN VALSALVA AORTIC PROSTHESIS
Manufacturer (Section D)
SORIN
MDR Report Key4727962
MDR Text Key15973064
Report NumberMW5042230
Device Sequence Number1
Product Code LWQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/13/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Model NumberCP-027
Device Catalogue NumberCP-027
Device Lot NumberS1169478-B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age57 YR
Patient Weight89
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