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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

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SORIN GROUP ITALIA S.R.L. CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS Back to Search Results
Model Number R5-023
Device Problem Insufficient Information (3190)
Patient Problem Endocarditis (1834)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
Device disposition presently unknown.
 
Event Description
On (b)(6) 2018 a patient received a carbomedics reduced r5-023 as part of the sure-avr trial.The manufacturer was notified of a serious adverse event which occurred on (b)(6) 2019.The patient received a reintervention due to valve endocarditis.The device was explanted.No replacement valve was identified.No further event information or patient information was received.
 
Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.
 
Manufacturer Narrative
The manufacturer has made several attempts to obtain further information from the site.At this time no further details regarding the event or device availability have been received.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Ultimately, based on the limited information available regarding the event and the device functionality between the time of implant and the time of explant, it is not possible to draw a definitive conclusion to the reported event.If the manufacturer receives additional information, the investigation will be reassessed.Fields changed: b4, g4, g7, h2, h6.
 
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Brand Name
CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
Type of Device
MECHANICAL HEART VALVE PROSTHESIS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vc
MDR Report Key9597277
MDR Text Key175253132
Report Number3005687633-2020-00099
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012784
UDI-Public(01)08022057012784(240)R5-023(17)AA04
Combination Product (y/n)N
PMA/PMN Number
P900060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/27/2023
Device Model NumberR5-023
Device Catalogue NumberCPHV
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer Received02/07/2020
04/29/2020
Supplement Dates FDA Received03/06/2020
04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight87
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