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 Insufficient Information (3190)

Patient Problems Chest Pain (1776); Death (1802); Endocarditis (1834); Multiple Organ Failure (3261)

Event Date 01/22/2017

Event Type  Death  

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 (0.33%, 0.07% patient-year) had two adverse events indicated as valve related: 'chest pain, subacute infective endocarditis' on (b)(6) 2016 and the patient passed away on (b)(6) 2017.The patient received the cphv-s5 on (b)(6) 2016.It was confirmed that the patient's endocarditis was treated pharmacologically.With antibiotic treatment, the patient had an apparent improvement and recovered to a generally acceptable condition.However, the patient's endocarditis was reportedly not completely resolved.On the discharge diagnosis, subacute infective endocarditis was indicated and the patient was advised for further anti-inflammatory treatment.The patient passed away on (b)(6) 2017 due to multi-organ failure.It is reported that the endocarditis was not resolved at the time of death.The device functionality and the relationship between the patient's endocarditis and the death were reportedly unknown.

Manufacturer Narrative

The 'date user facility/importer became aware of the event' was mistakenly indicated as 18 feb 2020 instead of 13 feb 2020 in the previous report submitted.This information has now been properly updated.The remainder of the information remains unchanged.

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.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.Furthermore, the antibiotic treatment initially improved the patient's health conditions, although no further information is available on the device functionality and the subsequent treatments performed after the discharge.Ultimately, since the device was not explanted and no further information was received, the root cause ultimately remains unknown.Should additional information be provided, the case will be re-assessed and a follow-up report will be submitted as applicable.

• 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: 9821828
• MDR Text Key: 183072611
• Report Number: 1718850-2020-01026
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)210204
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020,04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: S5-021
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death