MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number S5-021

Device Problem Perivalvular Leak (1457)

Patient Problems Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was informed on this event through the study publication 'summary report of clinical follow-up and statistical analysis of cphv-s5 prosthetic heart valve'.This study aims to evaluate the mid- and long-term safety of prosthetic heart valve after implantation through a retrospective follow-up analysis.A total of 300 patients were followed-up in this study.The results of this retrospective follow-up study showed that the cphv-s5 (carbomedics top hat) prosthetic heart valve has low incidences of related clinical events after implantation, with no occurrence of unexpected adverse events, thus has good mid- and long-term safety.Among the results presented in this study, one patient experienced two adverse events: on (b)(6) 2016, the following reoperation was performed: perivalvular leak and reoperative aortic valve replacement.The preoperative diagnosis was "after infective endocarditis avr and left coronary left ventricular leak closure; postoperative incomplete wound healing.The device was reportedly not explanted at the time of this procedure.On (b)(6) 2016, the following reoperation was performed "aortic valve replacement + vegetation removal + left ventricular diverticulum repair using artificial patch + ascending aorta widening".The preoperative diagnosis was "after left coronary sinus tumour left ventricular fistula repair 2.After aortic valve replacement 3.Cardiac function class iii 4.Heart failure 5.Sinus tachycardia".Endocarditis was confirmed in both adverse events.No other adverse impacts are reported for the patient after the re-intervention in (b)(6) 2016.

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.Based on the information available, it is not possible to establish a definitive root cause for the reported event, also because of the unclarity of the information presently available.However, based on the document review performed, which included a review of the sterility process, no manufacturing deficits were identified.Considering the rigorous sterilization process that each livanova device undergoes at the time of manufacture, verified during the document review, it is unlikely that the endocarditis was caused by the device.Ultimately, since the device explanted was not returned for analysis and no further information was received on the event and on the device functionality, the root cause ultimately remains unknown.Should additional information be provided, the case will be re-assessed and a follow-up report will be provided as applicable.

Manufacturer Narrative

The manufacturer received additional information on this event, clarifying that the device was explanted after the hospital admission in (b)(6) 2016.Based on the information available, it is not possible to establish a definitive root cause for the reported event.However, based on the document review performed, which included a review of the sterility process, no manufacturing deficits were identified.Considering the rigorous sterilization process that each livanova device undergoes at the time of manufacture, verified during the document review, and based on the information available, it is possible that the event was caused by the patient's specific clinical conditions.Ultimately, since the device explanted was not returned for analysis and no further information was received, the root cause ultimately remains unknown.Should additional information be provided, the case will be re-assessed and proper investigative actions will be taken as applicable.

Event Description

The manufacturer received additional information regarding this event confirming that the device was explanted in (b)(6) 2016.A second report has been created for the explant of the second valve in (b)(6) 2016 (ref 3005687633-2021-00110) as reported, a 29 years old patient received a carbomedics top hat model s5-021 on (b)(6) 2016.The pre-operative diagnosis was of infective endocarditis, aortic valve vegetation, aortic regurgitation, mitral and tricuspid valve enlargement, cardiomegaly, pulmonary hypertension, cardiac function grade iii.The patient underwent aortic valve replacement + mitral valve exploration + myocardial abscess and removal of leaflet neoplasm + left coronary sinus aneurysm ruptured into the aneurysm wall resection + repair of ventricular outlet.The patient received treatment after the surgery, and was discharged in good conditions on (b)(6) 2016.The patient was re-admitted to the hospital on (b)(6) 2016.A surgical incision about 20 cm in length was observed in the middle of the sternum, a fistula about 5 cm in length was observed in the upper third, a little necrotic tissue and exudate were observed in the fistula, with surrounding redness and slightly higher skin temperature.The heart rhythm was regular, the heart sounds were not significantly enhanced or weakened, and no pathological murmur was heard in any of the valve examination areas.The patient received active anti-infection and wound dressing change after admission.The patient had slow wound healing and experienced a sudden acute coronary syndrome on (b)(6) 2016.As the patient was in critical condition, a second avr was performed on (b)(6) 2016 due to pericardial effusion and perivalvular leakage.The pre-operative echo (performed on (b)(6) 2016) showed that the av artificial mechanical valve opened and closed well; regurgitation was seen under the aortic valve (visible perivalvular leakage 4mm to 7mm, visible abnormal attachment echo).The intraoperative findings revealed a poor healing of the original wound, mild retrosternal adhesion, no thickening of the ascending aorta, and significant enlargement.There was leakage thickening, curling, severe calcification, and junctional fusion around the valve near the left and right junction of the original imported mechanical aortic valve, about 5 mm in width, resulting in severe aortic insufficiency.The device was explanted and replaced with another top hat model s5-021 (eventually explanted in (b)(6) 2016, see ref 3005687633-2021-00110).The operation was uneventful and the patient returned to the icu.As informed previously, endocarditis was confirmed in both events ((b)(6) 2016).

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9822018
• MDR Text Key: 191914434
• Report Number: 3005687633-2020-00106
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)200730
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

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: 07/30/2020
• Device Model Number: S5-021
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 03/26/2020; 03/09/2021
• Supplement Dates FDA Received: 04/24/2020; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR