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

Model Number	R5-025
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770); Endocarditis (1834); Paresis (1998); Thromboembolism (2654)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, a patient received a carbomedics reduced heart valve r5-025 in aortic position.On (b)(6) 2017, the patient experienced a stroke and the device is reported as the suspected cause.On (b)(6) 2017, the device was explanted.The patient experienced right hemiparesis and global aphasia following this event.Despite the event refers to a malfunctioning prosthesis, these malfunctions are not further specified.
Additional 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 additional information received, both the pre-operative echo and intraoperative findings suggested the presence of possible endocarditis, which could have contributed to the thrombus apposition detected on the prosthesis.However, no further confirmation on the presence of endocarditis was received and, since the device was not returned for investigation, this aspect remains not confirmed.Ultimately, based on the limited information available on the patient's history and device functionality between the time of implant (2013) and the time of explant (2017), it is not possible to draw a definitive conclusion to the reported event.If the manufacturer will receive additional information, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2013, a patient received a carbomedics reduced heart valve r5-025 to replace the native bicuspid valve (pre-operative diagnosis: severe aortic insufficiency and aneurysm of the ascending aorta).During the same procedure, a longitudinal reduction of the ascending aorta was also performed.An uneventful postoperative course was reported and at discharge, a good device functionality was detected.The manufacturer was informed that on (b)(6) 2017, the patient was hospitalized due to stroke, right hemiparesis, and global aphasia.The event is reportedly likely resulting from thromboembolism originating from the mechanical valve.The echo performed in(b)(6) 2017 detected the presence of pannus deposition on the prosthesis, possible thrombus depositions and dysfunction of the prosthesis (stenosis).Endocarditis was suspected due to the reported symptoms of fever.On (b)(6) 2017, 4-weeks of antibiotic therapy was initiated to stabilize the clinic status of the patient.On (b)(6) 2017, a re-intervention was performed to replace the mechanical valve with a biological prosthesis.During the procedure, a ventricle-aortic disconnection was noted, similar to previous endocarditis.The postoperative course was uneventful.

• Brand Name: CARBOMEDICS REDUCED AORTIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9485269
• Report Number: 1718850-2019-01212
• Device Sequence Number: 3986722
• Product Code: LWQ
• UDI-Device Identifier: 08022057012791
• UDI-Public: (01)08022057012791(240)R5-025(17)180101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020
• Report Date (Section F): 11/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: R5-025
• Device Catalogue Number: R5-025
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR