CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021 manufactured by Sorin Group Italia S.r.l..

Event Text Entries

[183072611] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1718850-2020-01026
• MDR Report Key: 9821828
• Date Received: 2020-03-11
• Date of Report: 2020-03-11
• Date of Event: 2017-01-22
• Date Facility Aware: 2020-02-13
• Report Date: 2020-02-18
• Date Reported to Mfgr: 2020-02-18
• Date Mfgr Received: 2020-02-13
• Date Added to Maude: 2020-03-11
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Generic Name: MECHANICAL HEART VALVE PROSTHESIS
• Product Code: LWQ
• Date Received: 2020-03-11
• Model Number: S5-021
• Catalog Number: S5-021
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 10 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SORIN GROUP ITALIA S.R.L.
• Manufacturer Address: STRADA CRESCENTINO SNC SALUGGIA, VERCELLI US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2020-03-11