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

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.

• 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 Key: 11635027
• MDR Text Key: 261313954
• Report Number: 3005687633-2021-00110
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)200531
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• 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 Date: 05/31/2020
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR