MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number	CP-029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Left Ventricular Failure (1948); Thrombosis (2100)
Date of Event	10/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Since the device remains implanted (no autopsy performed), no inspection on the device is possible at this time.Further investigation is ongoing and a follow up will be provided upon completion of the investigation.
Event or Problem Description
On (b)(6) 2020, a patient received a carboseal valsalva model cp-029 as part of a standard bentall procedure.Aorta ascendens aneurisme 6,7cm.Parasystisk afib, pv isolation.The procedure went well, with no complications reported and the patient was moved to the icu.An initial uneventful postoperative course was reported.After 36 hours, the patient went into cardiac arrest, and was brought back to the operating room where an internal cardiac massage was started, then on bypass and cps within 25 minutes.Once the heart was stopped, upon examination they noticed a massive thrombosis in central part of prothesis occluding left main and lad coronary.Thrombosis was able to be evacuated giving retrograde plegia solution that pushed the thrombosis out.The left ventricle reportedly not pumping efficiently (ef 5-10% due to an infarction of the left ventricle).The patient was put under ecmo support and transferred to another facility (transplantation center) on (b)(6) 2020.It was reported that the patient passed away (exact day not yet informed).
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device carboseal valsalva model cp-029 and sn (b)(6) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since no autopsy was reportedly performed, no device inspection is possible at this time.Since the device remains implanted (no autopsy performed), no inspection on the device is possible at this time.The manufacturer attempted to retrieve additional information on the event, but no further information has been received to date.Should new information on this event be provided, livanova will provide an update to this reporting activity.
Additional Manufacturer Narrative
Updated f10 with the new health effect impact code.The information previously submitted remains unchanged.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10901554
• Report Number: 1718850-2020-01201
• Device Sequence Number: 19189731
• Product Code: LWQ
• UDI-Device Identifier: 08022057013576
• UDI-Public: (01)08022057013576(240)CP-029(17)220501
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2021
• Report Date (Section F): 10/27/2020

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: 05/01/2022
• Device Model Number: CP-029
• Device Catalogue Number: CP-029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/27/2020; 04/06/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/24/2020; 04/06/2021
• 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: Death; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 113