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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORCYM ITALIA CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

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CORCYM ITALIA CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS Back to Search Results
Model Number CPHV
Device Problem Perivalvular Leak (1457)
Patient Problems Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)
Event Date 10/13/2020
Event Type  Injury  
Event Description
On (b)(6) 2015, a patient received a carbomedics standard aortic prosthesis a5-023 for streptococcal endocarditis.At five months post procedure, there was evidence of stable moderate peri prosthetic regurgitation.The patient presented with fever and was admitted to the hospital on (b)(6) 2020 requiring metaraminol infusion.The echo/toe showed a borderline dilated left ventricle, hyperdynamic systolic function with moderate to severe prosthetic aortic regurgitation.No obvious vegetation was identified.The blood cultures have been negative and the serology for legionella was positive.The patient has hypoalbuminaemia.The coronary angiogram shows only minor disease.The patient underwent a re-do aortic valve replacement on (b)(6) 2020.The diagnosis was of possible culture negative endocarditis with legionella.The intraoperative findings showed a moderately large peri prosthetic space at the right coronary annulus.The underlying tissue was well healed.The remainder of the valve was extremely well incorporated in the annulus.There was no obvious vegetation or purulent material present.The explanted valve was replaced with a new a5-023.The procedure was completed uneventfully and the outcome was good.
 
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.Since the device was not returned to the manufacturer at the time of explant (and can be reasonably considered as discarded given the time elapsed since the explant), no further investigation is possible at this time.Based on the available information, given that no investigation on the actual device was possible, it is not possible to establish a definitive root cause for the reported event.However, the document review performed, which includes also a review of the sterilization performed at the time of manufacture and release, confirmed the absence of any manufacturing deficiencies on the device involved.Considering that the patient received the cphv valve due to endocarditis and that a stable moderate peri prosthetic regurgitation was visible at 5 months after the procedure, a possible root cause can be traced to the patient's specific baseline conditions.
 
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Brand Name
CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
Type of Device
MECHANICAL HEART VALVE PROSTHESIS
Manufacturer (Section D)
CORCYM ITALIA
strada crescentino
saluggia, vercelli
MDR Report Key11891772
MDR Text Key252880779
Report Number1718850-2021-01086
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012623
UDI-Public(01)08022057012623(240)A5-023(17)200306
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 07/21/2021,08/05/2021
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 Date03/06/2020
Device Model NumberCPHV
Device Catalogue NumberA5-023
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/21/2021
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer07/21/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/27/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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