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

Model Number TBD

Device Problems Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); No Information (3190)

Event Date 06/05/2019

Event Type  Injury  

Event Description

The manufacturer was informed that a patient received a carbomedics mechanical valve in mitral position on (b)(6) 2012 due to mitral insufficiency.The device was reportedly explanted on (b)(6) 2019 due to a prosthesis malfunction, however this aspect was not further clarified.The patient received a competitor's device.It is reported that in (b)(6) 2017, the patient was hospitalized for an external electrical conversion following the re-occurrence of symptoms of cardiopalm and dyspnea.The patient was discharged in both instances with no further treatment (no external electrical conversion performed), with a diagnosis of permanent atrial fibrillation.

Event Description

The manufacturer was informed that a patient received a carbomedics mechanical valve no.31 (model, sn unknown) in mitral position on (b)(6) 2012 due to mitral insufficiency.The device was reportedly explanted on (b)(6) 2019 due to a malfunction of the prosthesis.The patient received a competitor's device (st.Jude 31).It is reported that in (b)(6) and (b)(6) 2017, the patient was hospitalized for an external electrical conversion following the re-occurrence of symptoms of cardiopalm and dyspnea.The patient was discharged in both instances with no further treatment (no external electrical conversion performed), with a diagnosis of permanent atrial fibrillation.The manufacturer received additional information confirming that the postoperative course of the patient following the procedure of (b)(6) 2019 (replacement of carbomedics 31 mitral prosthesis with st jude epic 31 biological prosthesis and tricuspid annular plastic according to de vega) was regular without complications and discharge on the sixth postoperative day.Data on the device functionality between (b)(6) 2012 and (b)(6) 2017 are not available.On (b)(6) 2017 the patient was admitted to the cardiology clinic for dyspnea due to exertion in atrial fibrillation well coagulated in recent years with tao warfarin.On echocardiogram, the mechanical mitral prosthesis presented intermittent opening movement of the posterior hemidiscus without evidence of thrombosis or cloths, average gradient 7 mmhg.The stress echocardiogram ((b)(6) 2017) showed an improvement of the opening of the posterior leaflet of the prosthesis.Marked dilation of the left atria with spontaneous echo contrast in the outcome of surgical closure of the left auricle.The patient was discharged with a diagnosis of mild mitral mechanical dysfunction due to intermittent mild dysfunction of the prosthesis to open the posterior hemidiscus due to probable steric encumbrance of the posterior subvalvular apparatus.The patient was asymptomatic and with optimal hemodynamic compensation.The patient was also subjected to electrical cardioversion with restoration of sinus rhythm.On (b)(6) 2019, the echo showed an average gradient was 9 mm hg and the peak gradient was 15 mmhg.The gradients appeared increased compared to the previous echocardiographic checks (not available).One leaflet appeared blocked.T was possible to appreciated a thickened subvalvular apparatus, without evident vegetative or thrombotic formation.No leaks were observed.At the time of explant, the prosthesis showed a blocked leaflet.The prosthesis also presented a fibrotic pannus and thrombus clot partially occluding under the valve.The prosthesis is no longer available for return.As reported, the analysis performed on the prosthesis after explantation seems to indicate a subvalvular pannus problem rather than a malfunction of mechanical origin.The patient was on anticoagulant therapy with coumadin from the time of the first implant.The inr values at admission were in range.No values are available at the time of the 2012 plant and subsequent follow-up.

Manufacturer Narrative

Fields updated: b4, b5, f6, f7, f10.Since the device is not available for return and the serial number was not provided (unknown), no device investigation was possible and a definitive root cause cannot be established at this time.However, considering the information reported and medical judgment shared, the most probable root cause of the reported event (i.E.Blocked leaflet) can be traced to a subvalvular pannus problem rather than a malfunction of mechanical origin.

• Brand Name: CARBOMEDICS VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10796485
• MDR Text Key: 215092465
• Report Number: 1718850-2020-01191
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/11/2020,02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR