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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

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SORIN GROUP ITALIA SRL CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; 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 12/02/2016
Event Type  Injury  
Manufacturer Narrative
Unknown device disposition.
 
Event Description
The manufacturer received information on a top hat s5-021 explant that occurred on (b)(6) 2016.The device was implanted on (b)(6) 2016 as part of a re-do aortic valve replacement (avr).During the procedure, surgical treatment of wound infection was also performed.After implant, the top hat leaflets appeared well opened and closed without perivalvular leakage.The procedure was uneventful, and the patient was returned to the icu.The patient was postoperatively given anti-infection, cardiotonic, diuretic, potassium supplement and other symptomatic and supportive treatment.The patient was discharged on (b)(6) 2016 with improved condition.The echo performed on (b)(6) 2016 showed that the valve leaflets were opened and closed well, the pressure gradient was 28 mmhg and 25 mmhg, respectively, and no perivalvular leakage was observed in either echo exam.The echo performed on (b)(6) 2016 showed good opening and closing of valve leaflet, pressure gradient of 25 mmhg, and a visible perivalvular leakage.The diagnosis on discharge was of perivalvular leakage after avr for infective endocarditis; re-avr for perivalvular leakage; behcet's disease; latent tuberculosis.The patient was re-admitted to the hospital on (b)(6) 2016, after repair of left coronary sinus fistula, after aortic valve replacement, cardiac function grade iii, heart failure, sinus tachycardia.The patient had palpitation, shortness of breath and chest distress, without other obvious discomfort, which were relieved after rest and aggravated after activities.On (b)(6) 2016, the patient underwent emergency aortic valve replacement + vegetation removal + artificial patch repair + widening of ascending aorta.The echo performed on (b)(6) 2016 showed good opening and closing of valve leaflet, peripheral fixation of annulus, visible perivalvular leakage 2 mm, no abnormal attachment echo.At the time of the re-intervention, the pathological findings revealed extensive adhesions of the retrosternal anterior mediastinum and significant enlargement of the left ventricle.The root of the ascending aorta was not large, and the leakage around the original aortic valve was located at the left abjunctional peripheral bovine pericardial patch, about 1.2 cm in length.The right coronary valve and pericoronary valve have been covered with an intima and firmly fixed.Mitral valve - aortic valve curtain and the original pericardial patch of the room have dull colored tissue.A bentall procedure was performed, and the patient received a top hat s5-019 and an artificial blood vessel.The patient was critically ill and required high-dose vasoactive drug support.The patient was postoperatively given anti-infection, cardiotonic, diuretic, potassium supplement, heart protection and other symptomatic and supportive treatment, and was basically recovered and discharged.At the time of discharge, the general condition of the patient was good; echocardiography showed no perivalvular leakage or pericardial effusion, and chest radiography was consistent with postoperative changes.As informed previously, endocarditis was confirmed in both events ((b)(6) 2016, ref 3005687633-2020-00106, and (b)(6) 2016, this report).
 
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.The explanted prosthesis were discarded as medical waste per hospital routine practice.No further information was received about this event.Based on the available information, it is not possible to establish a definitive conclusion for the reported event.However, based on the document review performed no manufacturing deficiencies were identified.Considering the information reported, confirming that the leakage around the valve was located near to the pericardial patch, a possible root cause can be traced to the procedure/patient's factors.Ultimately, since no further information was received and since the device is not available for return, the root cause cannot be confirmed.Endocarditis is listed as a possible adverse event in the carbomedics top hat instructions for use (ifu).As such, the event is a known inherent risk of the device.H3 other text: device discarded.
 
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Brand Name
CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
Type of Device
MECHANICAL HEART VALVE PROSTHESIS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada crescentino
saluggia, vercelli
MDR Report Key11635027
MDR Text Key261313954
Report Number3005687633-2021-00110
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012906
UDI-Public(01)08022057012906(240)S5-021(17)200531
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
Report Date 05/12/2021
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 Date05/31/2020
Device Model NumberCPHV
Device Catalogue NumberS5-021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/09/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received04/12/2021
Supplement Dates FDA Received05/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age29 YR
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