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

Model Number CP-029

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Left Ventricular Failure (1948); Thrombosis (2100)

Event Date 10/22/2020

Event Type  Death  

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 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).

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.

Manufacturer Narrative

Updated f10 with the new health effect impact code.The information previously submitted remains unchanged.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10901554
• MDR Text Key: 218165992
• Report Number: 1718850-2020-01201
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013576
• UDI-Public: (01)08022057013576(240)CP-029(17)220501
• 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: 10/27/2020,04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 113